Catalogue_en

2015

EN

Reliable, efficient, safe • 02

iPerio • 30

Gold standard • 03

Shape1b • 35

Shape1: triple thread tapered self • 04

Shape1bn • 53

Connection with friction fit • 06

Shape1eh • 67

Management of soft tissues • 07

Shape1t • 81

Surface treatment • 08

Shape mini • 90

Cytotoxicity test • 10

Surgical and prosthetic instruments • 92

Cold plasma decontamination • 11

Implant system • 102

Surface treatments proposal on body of Shape1 • 12

Prosthetic components • 106

Gamma sterilization • 14

Rotary instruments • 110

Surgical kit • 16

Partnership • 114

Surgical protocol • 22

Support • 114

Baseline studies • 27

Certification • 115

- 01 -

RELIABLE EFFICIENT SAFE Designed and manufactured by the best dental professionals, facilitates surgical and prosthetic procedures and improves functional and aesthetic performance system rationalization, improving performance, continuing education, customer service, are our mission.

- 02 -

• triple thread tapered self-tapping implant • friction fit econometric connection • SLA surface treatment • soft tissue management • complex periodontal conditions implant • single implant design with different connections • platform switching - rationalization of the prosthetic components • one surgical kit

GOLD STANDARD SELECTION SYSTEMS AND PROCEDURES SIMPLIFICATION - 03 -

SHAPE 1: TRIPLE THREAD TAPERED SELF TAPPING IMPLANT s1b

s1eh

s1t

bone level with internal hex

bone level with external hex

transmucosal with internal octagon

The body implant design is the same for all the connections. The implant system shape1, in order to ensure the use of a smaller number of prosthetic components, while not giving up all solutions, supplies on all its lines bn, b, eh and t, one platform suitable for all the different implant diameters (Platform Switching).

- 04 -

bony ridge line

Platform switching 1 mm machined neck to protects from bacterial attacks Cutting coronal thread for a better forces discharge on cortical bone to provide excellent stability even in few millimeters

60° triple thread over the entire body implant with a pitch of 1,8 mm (0,6 mm/ thread); each turn allows to go down of 1,8mm, speeding up the insertion phase

3 apical aggressive cuts provide a better primary stability and centering of the implant and the possibility to change direction during its insertion Apex aggressive but rounded to protect the Schneider’s membrane - 05 -

UNIQUE DESIGN DIFFERENT CONNECTIONS

CONNECTION WITH FRICTION FIT For line s1b and s1bn with hexagonal internal connection a range of prosthetic components has been developed with Friction Fit connection, presenting 1° of taper on the walls of the post hexagon. This connection ensures a “cold weld” between implant and post if the retaining screw is tightened at 35 Ncm. This eliminates micromovements and significantly reduces bacterial infiltrations between implant and post.

- 06 -

1°

The connection between implant and post is present on the entire implant line with the configuration to be finished as shown in figure 1 or classic as in figure 2, depending on the diameter of the flaring required, respectively 3.5 mm or 5 mm. An emergence profile is also available, figure 3, which ensures a more rounded connection without sharp corners, creating a greater space for mucosa anchoring.

This profile which guarantees better conditioning of the soft tissues is contemplated on the whole prosthetic range, from healing screws right up to the final posts.

MANAGEMENT OF SOFT TISSUES

[figure 1] - 07 -

[figure 2]

[figure 3]

SURFACE TREATMENT

* Valutazione della composizione chimica superficiale, della morfologia, della citotossicità e dell’adesione cellulare su impianti dentali. G. Cascardo, C. Cassinelli.

Doctor OS 2005 Nov-Dic; 16 (9): 1091. Valutazione comparativa del trattamento di superficie in 5 sistemi implantari. M. Biasotto, M. Cadenaro et al. Università degli studi di Trieste. Quintessence International, Anno 18 – Maggio/Giugno 2002. RAPPORTO ISTISAN 01/15 – Valutazione del trattamento superficiale sulle prestazioni meccaniche a fatica di impianti in titanio plasma-sprayed e titanio sabbiato e mordenzato. Rossella Bedini, Gior-gio de Angelis, Marco Tallarico, Rosario Iealpi, Umberto Romeo, Giuseppe di Cintio 2001, 33 p. RAPPORTO ISTISAN 08/32 – Valutazione microtomografica

dell’area di possibile contatto osseo di sei tipologie diverse di impianti dentali.

Rossella Bedini, Raffaella Pec-ci, Fabio Di Carlo, Alessandro Quaranta, Francesca Rizzo, Manlio Quaranta, G. Heimke, W. Schulte, B. d’Hoedt, P. Griss, C.M. Büsing, D. Stock. The influence of fine surface structures on the osseo-integration of implants. The International Journal of Artificial Organs 1982; 5(3): 207-212. Guy, M.J. McQuade, M.J. Scheidt, J.C. McPherson III, J.A. Rossmann, T.E. Van Dyke. In vitro attachment of human gingival fibroblasts to endosse-ous implant materials. Journal of Periodontology 1993 Jun; 64(6): 542-546.

- 08 -

There is extensive scientific literature* on how surface roughness characteristics influence cell behaviour.

Compared to a smooth surface, topographical patterns smaller in size than a fibroblast cell (micro and nano topography) orient the arrangement of the cells and stimulate osteoblastic and platelet activity, accelerating the production of extracellular matrix and bone regeneration, and therefore the osseointegration of the dental implant.

The three fundamentals of surface treatment of dental implants from a biological point of view are: 1) control of surface topography to stimulate cellular response in an osteogenic direction; 2) control of the chemical composi-

tion of the surface to promote cell colonisation; 3) control of biological contamination from adherent endotoxins so as not to interfere with the natural inflammatory response. For the surface treatment a sand-blasting process was used followed by a double acid attack. In the images, increasing the magnification, it can be seen how the macroscopic aspects of the screw (spire, cutting edge) are not affected by the treatment and that the surface is free from processing residue. The dual-beam roughness typical of SLA treatment can be clearly observed, which contains large cavities due to large grit blasting on which is superimposed the microroughness due to treatment with acids. The microroughness illustrated

- 09 -

in the figures highlights the typical three-dimensional topography, which gives these surfaces “sponge-likeâ€? characteristics that are the basis of their excellent clinical performance In fact, the very short peak-to-peak distance, about 1 micrometer, stimulates both the activity of osteogenic cells and the capillary penetration of the blood in the surface structure, offering very favourable characteristics to stimulate bone regeneration, as described in many articles on this topic. This unique combination of long-range roughness (large grit sand-blasting) and short-range (acid etching) is a substrate favourable to cell regrowth that adequately promotes cell differentiation. The level of roughness is Ra 1.42 Âą 0.12.

CYTOTOXICITY TEST positive control

After treatment and decontamination, the implants proved to be perfectly cytocompatible, that is devoid of cytotoxic effects against L929 fibroblasts.

In all wells, the cells always showed density and morphology fully comparable with those of the negative control. The fibroblasts proliferate homogeneously in contact with the implants as the material does not release any cytotoxic element. Moreover, multinucleated giant cells were never shown in significantly higher number than the negative control, indicating the absence of effects of an inflammatory type.

negative control

sample tested

ISO 10993-5:2009. Biological evaluation of medical devices. Tests for in vitro cytotoxicity

- 10 -

COLD PLASMA DECONTAMINATION After the surface treatment, the implants are cleaned to remove processing residues by washing them with solvents and then subjecting them to a process of surface decontamination with cold plasma (Argon). The partially ionised Argon atoms (inert gas) act as an additional atomic sandblasting that promotes the removal of organic contaminants and

activates the ionisation of surface atoms of titanium, improving the wettability of the implant. The treatment conditions adopted on shape1 implants offer the best characteristics considered important, according to the state of current knowledge*, in the processes of implant healing, both in terms of surface morphology and in terms of chemical composition

* Valutazione del rapporto tra costo e qualità della pulizia superficiale di alcuni sistemi implantari in commercio Marco Morra, Clara Cassinelli, Giovanna Cascardo, Daniele Bollati, Nobil Bio Ricerche srl Via Valcastellana 26, 14037, Portacomaro (AT)

- 11 -

(surface cleaning). Plasma cleaning, packaging in a controlled environment, the absolute respect of “clean” procedures, quality control tests of during the manufacturing process, play a fundamental role in the control of adherent endotoxins (biological cleaning), the main agent of immunological response to implant surfaces.

M. Morra, C.Cassinelli, Evaluation of Surface Contamination of Titanium Dental Implants by Lu-Sem: Comparation with XPS Mesurements Surface and Interface Analysts, Vol. 25, 983-984 (1997).

SURFACE TREATMENTS PROPOSALS ON BODY OF SHAPE 1 IMPLANT SYSTEM - 12 -

s1b

s1b c

s1eh

s1t

Surface treatment on the whole body implant

Surface treatment on the body implant with 1 mm of machined neck

Surface treatment on the body implant with 0,7 mm of machined neck

Surface treatment on the body implant with 2,5 mm of machined neck

- 13 -

GAMMA STERILIZATION. IL PACKAGING To preserve its integrity, the dental implant is housed in a vertical position inside a titanium cylinder anchored, by means of the closing cap, to the respective vial made of borosilicate glass for pharmaceutical use, complying with the European Pharmacopoeia in force.

This vial really ensures the neutrality of the primary packaging due to the absence of release of contaminants during the sterilisation phase.

- 14 -

It is inserted in a blister of transparent polyglass sealed with heat-sealing lacquer-based Tyvek and packed in a cardboard box that also contains the instructions for use and the labels for the patient records, on which are printed the data that allow product traceability (code and batch number). All the product packaging materials have been tested, approved and certified.

Shape1 implants are supplied sterile, in a pack that allows their stability to be guaranteed for 5 years. The sterilisation process is performed with gamma rays respecting the standards in force by qualified suppliers who use automated, safe and reliable systems, with continuous microbiological monitoring of the process.

*European Pharmacopoeia, current edition, 3.2.1 Glass containers for pharmaceutical use.

- 15 -

SURGICAL KIT CLEANING 1] Dismantle all the compound parts. 2] Rinse abundantly in cold or lukewarm water for 2-5 minutes. 3] Leave the instruments for 10 minutes in an ultrasonic cleaner with a neutral pH enzymatic detergent diluted in water according to the product instructions. 4] Wash the instruments with water for 3 minutes.

STERILISATION The guidelines for sterilisation are listed below.

Type of cycle (steam) Pre-vacuum Pre-vacuum Gravity

Temperature (째C/F) 132 / 270 134 / 273 121 / 250

Exposure time 3 minute 18 minute 80 minute

Drying time 30 minute 30 minute 30 minute

If these sterilisation parameters are exceeded it may cause deterioration of the plastic components.

- 16 -

The purpose of surgical trays is to keep the instruments used for inserting dental implants. The trays thus assembled can be carried, sterilised and kept in a horizontal position with the lid closed.

All the instruments must be cleaned and sterilised for the first use.

The kit and the instruments that it contains are not sterile at the time of delivery.

- 17 -

SURGICAL KIT COMPONENTS COMPLETE

- 18 -

Code

Description

Ă˜ mm

h mm

Code

Description

Ă˜ mm

DS43337

drill stop

33/37

4

CSD41

countersink

4,1

DS63337

drill stop

33/37

6

TAP41

tap

4,1

h mm

DS83337

drill stop

33/37

8

D3844S

short drill

3,8/4,4

32

DS103337

drill stop

33/37

10

D3844L

long drill

3,8/4,4

39

DS113337

drill stop

33/37

11,5

CSD47

countersink

4,7

DS133337

drill stop

33/37

13

TAP47

tap

4,7

DS44147

drill stop

41/47

4

PP

parallel pin

DS64147

drill stop

41/47

6

PP

parallel pin

DS84147

drill stop

41/17

8

DE

drill extender

DS104147

drill stop

41/47

10

HD21S

short hand conn. for s1bn

2,1

DS114147

drill stop

41/47

11,5

HD21L

long hand conn. for s1bn

2,1

22

DS134147

drill stop

41/47

13

HDH21L

handpiece conn. for s1bn

2,1

30

14

LD

lance drill

2

HD25S

short hand conn. for s1bn

2,5

14

D23S

short pillot drill

2,3

32

HD25L

long hand conn. for s1bn

2,5

22

D23L

long pillot drill

2,3

39

HDH25L

handpiece conn. for s1bn

2,5

30

D2428S

short pillot drill

2,4/2,8

32

HD31S

short hand conn. for s1bn

3,1

14

D2428L

long pillot drill

2,4/2,8

39

HD31L

long hand conn. for s1bn

3,1

22

TAP33

tap

3,3

IDS

short hand screwdriver

D2833S

short drill

2,8/3,3

32

MDS

short hand connector

1,25

23

D2833L

long drill

2,8/3,3

39

MDL

long hand connector

1,25

29

CSD37

countersink

3,7

THDD

handle screwdriver

1,25

TAP37

tap

3,7

TW

dynamometric ratchet

D3338S

short drill

3,3/3,8

32

ID

long hand screwdriver

D3338L

long drill

3,3/3,8

39

bowl - 19 -

csd37

csd47

d2428l

hdh21l

- 20 -

tap47

hd31l

SURGICAL KIT COMPONENTS BASE Code

Description

PP

parallel pin

Ø mm

h mm

Code

Description

Ø mm

h mm

D3844L

long drill

3,8/4,4

39

4,7

D23L

long pillot drill

2,3

39

CSD47

countersink

D2428L

long pillot drill

2,4/2,8

39

TAP47

tap

4,7

D2833L

long drill

2,8/3,3

39

HD25S

short hand conn. for s1bn

2,5

14

CSD37

countersink

3,7

HDH25L

handpiece conn. for s1bn

2,5

30

TAP37

tap

3,7

THD

handle screwdriver

1,25

23

D3338L

long drill

3,3/3,8

IDS

short hand screwdriver

CSD41

countersink

4,1

R

short hand screwdriver

TAP41

tap

4,1

39

- 21 -

SURGICAL PROTOCOL USER INSTRUCTIONS The shape1 implant system is indicated for surgical treatment in the upper and lower jaw for the partial or total replacement of teeth in patients who have lost part or all of their teeth.

The implant to be used must be chosen by the medical personnel

based on the medical history and on the subsequent surgical and prosthetic plan required for each individual patient. The shape1 implant is delivered in sterile packs and the operator must pay great attention when positioning it in the oral cavity, so that the implant does not come in contact with elements - 22 -

that could alter the surface, hindering the healing processes, so all manoeuvres must be performed in an environment suitable for surgical activities.

The shape1 implant system has a series of dedicated surgical instruments for its implant lines, useful for the non-traumatic

s1 | 3,3 soft bone d3 d4

s1 | 3,3 compact bone d1 d2

01

02

01

02

03

lance drill

pilot drill 2.3 mm

lance drill

pilot drill 2.3 mm

drill 2.4 - 2.8 mm

04

optional

tap 3.3 mm

s1 | 3,7 soft bone d3 d4 01

02

03

04

optional, based on the suitable insertion torque lance drill

pilot drill 2.3 mm

drill 2.4 - 2.8 mm

countersink 3.7 mm

s1 | 3,7 compact bone d1 d2 01

02

03

04

05

lance drill

pilot drill 2.3 mm

drill 2.4 - 2.8 mm

drill 2.8 - 3.3 mm

countersink 3.7 mm

- 23 -

06

optional

tap 3.7 mm

s1 | 4,1 soft bone d3 d4 01

02

03

04

optional, based on the suitable insertion torque lance drill

pilot drill 2.3 mm

drill 2.8 - 3.3 mm

countersink 4.1 mm

s1 | 4,1 compact bone d1 d2 01

02

03

04

05

06

lance drill

pilot drill 2.3 mm

drill 2.8 - 3.3 mm

drill 3.3 - 3.8 mm

countersink 4.1 mm

optional

tap 4.1 mm

s1 | 4,7 soft bone d3 d4 01

02

03

04

05

optional, based on the suitable insertion torque lance drill

pilot drill 2.3 mm

drill 2.8 - 3.3 mm

drill 3.3 - 3.8 mm

- 24 -

countersink 4.7 mm

preparation of the site that is to receive the implant, and instruments designed for extracting the implant from the blister and transporting it to the mouth for insertion.

Each blister containing the implant is provided with a closing screw, useful for sealing the internal part of the implant after it has been inserted in the mandibular or maxillary bone.

PRE-OPERATIVE PLANNING The careful study and assessment of patients who are candidates for implant-prosthetic therapy is of fundamental importance. Physical, instrumental, and radiological examinations and the study of models allow the dentist to make the best diagnosis and consequent therapy. The preparation of the patient for surgical implant therapy and the preparation of the operating room must be given the same care and attention as general surgery;

the preparation of the implant site using dedicated drills with controlled revolutions, cooled with saline solution, these are all indispensable conditions for implant therapy.

PREPARATION OF THE SURGICAL SITE AND SURGICAL SEQUENCE The preparation of the surgical site to receive the implant must be performed as far as possible with surgical techniques that reduce the traumatic nature of the operation, so it is important to respect the organic tissues so as to reduce the surgical impact.

The reduction of trauma may be obtained with the sequential use of I-RES dental drills which must necessarily be used as tools to perforate the bone. The diameters to be used, the lengths and the drilling sequence (number of drills to be used) are the sole choice and - 25 -

decision of the dentist, depending on the surgical protocol that must be followed. The maximum recommended speed is 800 rpm with saline solution applied directly on the drill to assist cooling.

CHARACTERISTICS OF THE DRILLS I-RES drills are made with new tempering technologies and selected surgical steels to make cutting more efficient.

I-RES drills for finalising have three cutting edges to increase their cutting capacity and stability during preparation of the surgical site, and with different diameters between the apical and coronal portion they increase fitting with the implant.

All the drills in the I-RES implantprosthetic system are colour-coded to facilitate the correct selection of the instrument and its subsequent reassembly, and laser-marked to

s1 | 4,7 compact bone d1 d2 01

02

03

04

05

lance drill

pilot drill 2.3 mm

drill 3.3 - 3.8 mm

drill 3.8 - 4.4 mm

countersink 4.7 mm

improve visibility of the height while working. All the drills in the I-RES implant-prosthetic system are colour-coded to facilitate the correct selection of the instrument and its subsequent reassembly, and laser-marked to improve visibility of the height while working. Long drills offer the possibility of fitting surgical stops at the various heights to help the dental surgeon and prevent the cutting instrument going beyond the

planned level.

Countersinks are used when it is necessary to widen the initial part of the hole made to adapt the shape that of the neck of the implant to be inserted. The maximum recommended speed is 300 rpm with saline solution applied directly on the drill to assist cooling.

Bone taps: in particularly dense bone (type I), before inserting the implant it is advisable to use a bone type with - 26 -

06

optional

tap 4.7 mm

the same profile as the implant to be inserted. The bone tap has a greater cutting power than the implant, allowing the site to be prepared with reduced trauma. The maximum recommended speed is 30 rpm with saline solution applied directly on the bone tap to assist cooling. Maximum number of uses of the devices: 25 times.

BASELINE STUDIES IMPLANT DESIGN Hansson S., The implant neck: Smooth or provided with retention elements. A biomechanical approach. Clinical Oral Implants Research 1999; 10(5): 394-405.

O’Sullivan D., Sennerby L., Meredith N., Influence of implant taper on the primary and secondary stability of osseointegrated titanium implants. Clin Oral Implants Res. 2004; 15(4): 474-80.

O’Sullivan D., Sennerby L., Meredith N., Measurements comparing the initial stability of five designs of dental implants: a human cadaver study. Clin Implant Dent Relat Res. 2000; 2(2): 85-92.

Eraslan O, Inan O., The effect of thread design on stress distribution in a solid screw implant: a 3D finite element analysis. Clin Oral Investig. 2010 Aug; 14(4): 411-6. Epub 2009 Jun 20.

Huang H.L., Fuh L.J., Ko C.C., Hsu J.T., Chen C.C., Biomechanical effects of a maxillary implant in the augmented sinus: a three-dimensional finite element analysis. Int J Oral Maxillofac Implants. 2009 May-Jun; 24(3): 455-62.

Tepper G., Haas R., Zechner W., Krach W., Watzek G., Three-dimensional finite element analysis of implant stability in the - 27 -

atrophic posterior maxilla: a mathematical study of the sinus floor augmentation. Clin Oral Implants Res. 2002 Dec; 13(6): 657-65.

Chong L., Khocht A., Suzuki J.B., Gaughan J., Effect of implant design on initial stability of tapered implants. J Oral Implantol. 2009; 35(3): 130-5.

Cavallaro J. Jr, Greenstein B., Greenstein G., Clinical methodologies for achieving primary dental implant stability: the effects of alveolar bone density. J Am Dent Assoc. 2009 Nov; 140(11): 1366-72.

Molly L., Bone density and primary stability in implant therapy. Clin Oral Implants Res. 2006 Oct; 17 Suppl 2: 124-35.

Trisi P., De Benedittis S., Perfetti G., Berardi D., Primary stability, insertion torque and bone density of cylindric implant ad modum Branemark: Is there a relationship? An in vitro study. Clin Oral Implants Res. 2010 Nov 19. doi: 10.1111/j.16000501.2010.02036.x. (Epub ahead of print).

Trisi P., Perfetti G., Baldoni E., Berardi D., Colagiovanni M., Scogna G., Implant micromotion is related to peak insertion torque and bone density. Clin Oral Implants Res. 2009 May; 20(5): 467-71.

Ao J., Li T., Liu Y., Ding Y., Wu G., Hu K., Kong L. Optimal design of thread height and width on an immediately loaded cylinder implant: a finite element analysis. Comput Biol Med. 2010 Aug; 40(8): 681-6.

SURFACE TREATMENT Roccuzzo M., Bonino L., Dalmasso P., Aglietta M., Long-term results of a three arms prospective cohort study on implants in periodontally compromised patients: 10-year data around sandblasted and acid-etched (SLA) surface. Clin Oral Implants Res. 2013 Jul 19. doi: 10.1111/clr.12227. (Epub ahead of print).

Persson L.G., Berglundh T., Lindhe J., Sennerby L., Re-osseointegration after treatment of peri-implantitis at different - 28 -

implant surfaces. An experimental study in the dog. Clin Oral Implants Res. 2001; 12(6): 595-603.

Le Guehennec L., Lopez-Heredia M.A., Enkel B., Weiss P., Amouriq Y., Layrolle P., Osteoblastic cell behaviour on different titanium implant surfaces. Acta Biomater. 2008; 4(3): 535-43.

Cochran D.L., Nummikoski P.V., Higginbottom F.L., Hermann J.S., Makins S.R., Buser D., Evaluation of an endosseous titanium implant with a sandblasted and acid-etched surface in the canine mandible: radiographic results. Clin Oral Implants Res 1996; 7(3): 240–252.

Cochran D.L., Schenk R.K., Lussi A., Higginbottom F.L., Buser D., Bone response to unloaded and loaded titanium implants with a sandblasted and acid-etched surface: a histometric study in the canine mandible. J Biomed Mater Res 1998; 40(1): 1–11.

Buser D., Nydegger T., Hirt H.P., Cochran D.L., Nolte N.P., Interface shear strength of titanium implants with a sandblasted and acid-etched surface: a biomechanical study in the maxilla of miniature pigs. J Biomed Mater Res 1999; 45(2): 75-83.

PLATFORM SWICHTING Atieh M.A. et al., Platform switching for marginal bone preservation around dental implants: A systematic review and meta-analysis. Journal of Periodontology 2010; 81(10): 1350-66.

Annibali S. et al., Peri-implant marginal bone level: a systematic review and meta-analysis of studies comparing platform switching versus conventionally restored implants. Journal of Clinical Periodontology 2012; 39(11): 1097-113.

- 29 -

MODERN IMPLANT, TAPERED SELF TRIPLE THREAD WITHOUT SURFACE TREATMENT. - 30 -

s1-s

For the periodontopathic patient and against peri-implantitis, I-RES proposes an implant in a modern self-threading tapered version with triple spire, on the whole implant line (s1bn, s1b, s1eh, s1t) in a machined version without surface treatment, only cold plasma decontamination which, as well as removing processing residue from the implant, guarantees greater hydrophilic properties of the surface.

It resumes the same Branemark philosophy which amply

demonstrated that it works, but in a modern key. The osseointegration times will obviously be longer than with implants having a treated surface, but they will protect against bacterial attacks so they will be more indicated for patients in periodontal treatment.

Available on request (at a price of 150 euro) with all the connections, delivery time 3 weeks; replacement of sizes is not possible.

- 31 -

No surface treatment, only plasma cold decontamination

2 mm di ampiezza biologica, su tutta la componentistica protesica senza angoli vivi per un miglior sigillo mucoso 0,5mm Platform Switching e 0,5mm di collo dritto spire coronali taglienti per un miglior scarico delle forze sulla corticale che garantiscono un’ottima stabilità anche in pochi millimetri di osso tripla spira a 60° su tutto il corpo dell’impianto con un passo totale di 1,8mm (0,6 mm per spira); ogni giro d’inserzione consente una discesa di 1,8mm velocizzando la fase di inserimento 3 tagli apicali aggressivi garantiscono una migliore stabilità primaria e centratura dell’impianto e di variarne la direzione in fase d’inserzione apice aggressivo ma arrotondato a protezione della membrana di Schneider d 3,3 . 3,7 . 4,1 . 4,7 | h 4 . 6 . 8 . 10 . 11,5 . 13 . 16

- 32 -

Protesica: Sono disponibili tutte le soluzioni protesiche: analoghi, viti di guarigione, transfer da impronta diretta e indiretta, STRAIGHT ABUTMENTS e angolati [(20° e 25°) (standard e anatomici)], gold abutment, calcinabili, rotanti e non, monconi a sfera, locator, mua (dritti a 18° e 30°) e tutta la componentistica per la protesi avvitata.

Decontaminazione: Dopo la lavorazione meccanica, l’impianto viene pulito dai residui di lavorazione mediante lavaggi con solventi e successivamente sottoposto ad un processo di decontaminazione superficiale mediante plasma freddo (Argon).

Gli atomi parzialmente ionizzati dell’Argon (gas inerte) agiscono come un’ulteriore sabbiatura atomica che promuove la rimozione dei contaminanti orga-nici ed attiva la ionizzazione degli atomi superficiali del titanio, migliorando la bagnabilità dell’impianto. La pulizia con plasma, la pratica di confezionamento in ambiente controllato, l’assoluto rispetto di pro-cedure “pulite”, i test di controllo qualità durante il processo produttivo, giocano un ruolo fondamentale nel controllo delle endotossine adese (pulizia biologica), principale agente di risposta immunologi-ca alle superfici implantari.

Connessione: Per l’impianto iPerio con connessione esagonale interna, è stata sviluppata una componentistica protesica con attacco Friction Fit, che presenta 1° di conicità sulle pareti dell’esagono del moncone.

Que-sta connessione garantisce una “saldatura a freddo” tra impianto e moncone se la vite di ritenzione vien-ne serrata a 30 Ncm, rendendola passiva. Questo elimina i micromovimenti e le infiltrazioni batteriche tra impianto e moncone.

- 33 -

ø 3.7

ø 4.1

ø 4.7 44° angled for a guided insertion of the abutment top view

bony ridge line

Material Connection Diameter Platform Diameter Heights

Ti-Gr.4 internal hex 2.5 mm 3.5 mm 3.7 | 4.1 | 4.7 mm 6 | 8 | 10 | 11.5 | 13 | 16 | 18 mm - 34 -

B

3.7

h 8 | 10 | 11.5 | 13 | 16 mm

4.1

- 35 -

4.7

h 6 | 8 | 10 | 11.5 | 13 | 16 mm

3.7

4.1

4.7

Letter a b c d e f

Description neck height + platform switching apical core width apical coil width core coronal width core coil width maximum implant width

Measure [mm] 0.9 2.25 3 3.1 3.7 3.75

Letter a b c d e f

Description neck height + platform switching apical core width apical coil width core coronal width core coil width maximum implant width

Measure [mm] 0.95 2.60 3.35 3.45 4.05 4.1

Letter a b c d e f

Description neck height + platform switching apical core width apical coil width core coronal width core coil width maximum implant width

Measure [mm] 1 3.25 4 4.1 4.65 4.7

- 36 -

3.7

a

4.1

a

4.7

a

b

b

b

c

c

c

d

d

d

e

e

e

f

f

f

- 37 -

SHAPE 1B INTEGRAL TREATMENT code

ø 3.5 mm •

2.5 mm • screw S1BCS included

ø mm

h mm

quantity

material

price (€)

S1B378 S1B3710 S1B3711 S1B3713 S1B3716

3.75 3.75 3.75 3.75 3.75

8 10 11.5 13 16

1 1 1 1 1

TI GR4 TI GR4 TI GR4 TI GR4 TI GR4

130.00 130.00 130.00 130.00 130.00

S1B416 S1B418 S1B4110 S1B4111 S1B4113 S1B4116

4.1 4.1 4.1 4.1 4.1 4.1

6.5 8 10 11.5 13 16

1 1 1 1 1 1

TI GR4 TI GR4 TI GR4 TI GR4 TI GR4 TI GR4

130.00 130.00 130.00 130.00 130.00 130.00

S1B476 S1B478 S1B4710 S1B4711 S1B4713 S1B4716

4.7 4.7 4.7 4.7 4.7 4.7

6.5 8 10 11.5 13 16

1 1 1 1 1 1

TI GR4 TI GR4 TI GR4 TI GR4 TI GR4 TI GR4

130.00 130.00 130.00 130.00 130.00 130.00

- 38 -

SHAPE 1Bc MACHINED NECK code

ø 3.5 mm •

2.5 mm • screw S1BCS included

ø mm

h mm

quantity

material

price (€)

S1B378C S1B3710C S1B3711C S1B3713C S1B3716C

3.75 3.75 3.75 3.75 3.75

8 10 11.5 13 16

1 1 1 1 1

TI GR4 TI GR4 TI GR4 TI GR4 TI GR4

125.00 125.00 125.00 125.00 125.00

S1B416C S1B418C S1B4110C S1B4111C S1B4113C S1B4116C

4.1 4.1 4.1 4.1 4.1 4.1

6.5 8 10 11.5 13 16

1 1 1 1 1 1

TI GR4 TI GR4 TI GR4 TI GR4 TI GR4 TI GR4

125.00 125.00 125.00 125.00 125.00 125.00

S1B476C S1B478C S1B4710C S1B4711C S1B4713C S1B4716C

4.7 4.7 4.7 4.7 4.7 4.7

6.5 8 10 11.5 13 16

1 1 1 1 1 1

TI GR4 TI GR4 TI GR4 TI GR4 TI GR4 TI GR4

125.00 125.00 125.00 125.00 125.00 125.00

- 39 -

SURGICAL | PROSTHETIC SCREWS code

description

S1BCS

surgical

S1BRS1

included in the implant and prosthetic packaging - available as spare parts

ø mm

thread mm

quantity

material

price (€)

3.1

1.72

1

TI-6AI-4V

15.00

retained abutments

1.72

1

TI-6AI-4V

15.00

S1BRS2

retained mua

1.72

1

TI-6AI-4V

15.00

S1BRS3

retained for mua components

1.4

1

TI-6AI-4V

15.00

S1BDTRS

retained long transfer

1.72

1

TI-6AI-4V

15.00

S1BDTRSA

retained long transfer mua

1.4

1

TI-6AI-4V

15.00

- 40 -

HEALING SCREWS code

ø mm

h mm

quantity

material

price (€)

S1B3530HC S1B3545HC S1B3560HC

3.5 3.5 3.5

3 4.5 6

1 1 1

TI-6AI-4V TI-6AI-4V TI-6AI-4V

25.00 25.00 25.00

S1B5030HC S1B5045HC

5 5

3 4.5

1 1

TI-6AI-4V TI-6AI-4V

25.00 25.00

S1B5060HC

5

6

1

TI-6AI-4V

25.00

IMPRESSION DIRECT TRANSFERS code

screw S1BDTRS included

ø mm

quantity

material

price (€)

S1BDT35

3.5

1

TI-6AI-4V

35.00

S1BDT50

5

1

TI-6AI-4V

35.00

5

1

TI-6AI-4V

40.00

S1BDT350

description

a 3 componenti sfilabili

- 41 -

ANALOG code

quantity

material

price (€)

S1BIA

1

TI-6AI-4V

21.00

IMPRESSION INDIRECT TRANSFERS • STRAIGHT ABUTMENTS code

description

screw S1BRS1 included | *ITC included

ø mm

quantity

material

price (€)

S1B135ITC*

3.5

1

TI-6AI-4V

60.00

S1B150ITC*

5

1

TI-6AI-4V

60.00

ITC

indirect transfer cap

S1B1A50

mount | transfer | abutment

5

5

- 42 -

1

20.00

TI-6AI-4V

55.00

PEEK TEMPORARY STRAIGHT ABUTMENT code

screw S1BRS1 included

ø mm

quantity

material

price (€)

4

TI-6AI-4V

21.00

S1B1P35

STRAIGHT ABUTMENTS WITH FRICTION FIT code

description

screw S1BRS1 included

ø mm

h mm

quantity

material

price (€)

S1B135F

3.5

1

TI-6AI-4V

65.00

S1B150F

5

1

TI-6AI-4V

65.00

1 1

TI-6AI-4V TI-6AI-4V

75.00 75.00

1 1

TI-6AI-4V TI-6AI-4V

65.00 65.00

S1B1145F S1B1345F

anatomic anatomic

4.5 4.5

S1B145FS S1B155FS

without straight neck without straight neck

4.5 5.5 - 43 -

1 3

ANGLED ABUTMENTS WITH FRICTION FIT

*

code

angle

S1B2125F S1B225FSITCA*

25° anatomic 25° without s.n.

screw S1BRS1 included

ø mm

h mm

quantity

material

price (€)

4.5 5

1

1 1

TI-6AI-4V TI-6AI-4V

75.00 80.00

1 1

TI-6AI-4V TI-6AI-4V

75.00 75.00

1 1

TI-6AI-4V TI-6AI-4V

75.00 75.00

transfer per impianto pterigoideo

S1B245FS S1B250F

20° without s.n.

20°

4.5 5

S1B2145F S1B2345F

17° anatomic 17° anatomic

4.5 4.5

1 3

STRAIGHT MULTI UNIT ABUTMENTS (multi unit abutment) code S1B41 S1B42 S1B44 S1B46

screw S1BRS2 included

ø mm

h mm

quantity

material

price (€)

5 5 5 5

1 2 4 6

1 1 1 1

TI-6AI-4V TI-6AI-4V TI-6AI-4V TI-6AI-4V

55.00 55.00 55.00 55.00

- 44 -

CASTABLE ABUTMENTS

screw S1BRS1 included

code

description

ø mm

quantity

material

price (€)

S1B3GA45

gold base castable

4.5

1

POM-C/AU&PGM*

110.00

S1B3PC45

plastic castable

4.5

1

POM-C

29.00

S1B3PCR45

plastic castable no ex

4.5

1

POM-C

29.00

ANGLED MULTI UNIT ABUTMENTS (multi unit abutment) code

description

S1B518 S1B530

18° 30°

screw S1BRS2 included

ø mm

quantity

material

price (€)

5 5

1 1

TI-6AI-4V TI-6AI-4V

85.00 85.00

- 45 -

COMPONENTS FOR MUA (multi unit abutment)

*screw S1BRS3 included | **screw S1BDTRSA included

code

description

quantity

material

price (â‚Ź)

S1BHCSRA

healing cup*

1

POM-C

25.00

S1BDTCSRA impression direct transfer with long screw**

1

TI-6AI-4V

35.00

S1BITCSRA

impression transfer indirect*

1

TI-6AI-4V

35.00

S1BIASRA

analog

1

TI-6AI-4V

21.00

S1BTTA

temporary abutment*

1

TI-6AI-4V

45.00

S1BPCC

plastic castable*

1

POM-C

29.00

- 46 -

BALL ABUTMENTS

cah e calt included

code S1B61 S1B62 S1B64 S1B65

ø mm

h mm

quantity

material

price (€)

4 4 4 4

1 2 4 5

1 1 1 1

TI-6AI-4V TI-6AI-4V TI-6AI-4V TI-6AI-4V

45.00 45.00 45.00 45.00

quantity

material

price (€)

code

description

CAH

cap attachment housing (containment ring)

2

TI-6AI-4V

30.00

CALT

cap attachment liner (standard retention)

2

NYLON

15.00

BONDING BASE WITH FRICTION FIT code

S1B705F

calt included

ø mm

h mm

quantity

material

price (€)

4.5

0.5

1

TI-6AI-4V

45.00

- 47 -

LOCATOR code

h mm

quantity

material

price (€)

8661 8662 8663 8664 8665 8626

0 1 2.5 3.5 4.5 6.5

1 1 1 1 1 1

TIN TIN TIN TIN TIN TIN

95.00 95.00 95.00 95.00 95.00 95.00

code

description

quantity

material

price (€)

8530

analog for female Locator®

4

AI

50.00

8505

indirect impression tear pin for Locator®

4

AI

50.00

8519

set of cups and rings for parallel implants

2

Ti | NYLON

55.00

8540

set of cups and rings extended to disparallel implants

2

Ti | NYLON

55.00

- 48 -

SPARE PARTS: TEFLON RINGS AND CUPS code

description

quantity

material

price (€)

8524

resistant transparent male (2,3 Kg)

4

NYLON

30.00

8527

light pink male (1,4 Kg)

4

NYLON

30.00

8529

ultralight male blue (700 gr)

4

NYLON

30.00

8547

10°/20° angled for disparallelism, light male (1,5 Kg)

4

NYLON

30.00

8915

10°/20° angled light male (900 gr)

4

NYLON

30.00

8548

10°/20° angled ultralight male (500 gr)

4

NYLON

30.00

- 49 -

EQUATOR • COMPLETE PACKAGE (abutments, rings, caps) code S1B130-0 S1B130-1 S1B130-2 S1B130-3 S1B130-4 S1B130-5 S1B130-6 code

description

144AE

h mm

quantity

material

price (€)

0.5 1 2 3 4 5 6

1 1 1 1 1 1 1

TIN TIN TIN TIN TIN TIN TIN

115.00 115.00 115.00 115.00 115.00 115.00 115.00

quantity

material

price (€)

analog for Equator®

2

AI

38.00

044CAIN

indirect impression tear pin for Equator®

2

AI

25.00

100PD

protective disk

10

EVA

7.00

- 50 -

SPARE PARTS: RINGS AND CUPS code

description

quantity

material

price (â‚Ź)

141CAE

inox container for cups

2

SURG. STEEL

20.00

140CEG

yellow, extrasoft retention

4

TEFLON

28.00

140CER

pink, soft retention

4

TEFLON

28.00

140CET

transparent, standard retention

4

TEFLON

28.00

140CEV

violet, strong retention

4

TEFLON

28.00

- 51 -

ø 3.3 44° angled for a guided insertion of the abutment top view

bony ridge line

Material Connection Diameter Platform Diameter Heights

Ti-Gr.4 internal hex 2.1 mm 3.2 mm 3.3 mm 10 | 11.5 | 13 | 16 mm - 52 -

Bn

3.3

h 10 | 11.5 | 13 | 16 mm

- 53 -

3.3

Letter a b c d e f

Description neck height + platform switching apical core width apical coil width core coronal width core coil width maximum implant width

- 54 -

Measure [mm] 0.6 1.75 2.75 3.1 3.25 3.3

3.3

a

b c d e f

- 55 -

SHAPE 1BNc

ø 3.2 mm •

code

S1BN3310C S1BN3311C S1BN3313C S1BN3316C

2.1 mm • screw S1BNCS included

ø mm

h mm

quantity

material

price (€)

3.3 3.3 3.3 3.3

10 11.5 13 16

1 1 1 1

TI-6AI-4V TI-6AI-4V TI-6AI-4V TI-6AI-4V

130.00 130.00 130.00 130.00

- 56 -

SURGICAL | PROSTHETIC SCREWS code

description

S1BNCS

surgical

S1BRS1

included in the implant and prosthetic packaging - available as spare parts

ø mm

thread mm

quantity

material

price (€)

3.2

1.72

1

TI-6AI-4V

15.00

retained abutments

1.72

1

TI-6AI-4V

15.00

S1BRS2

retained mua

1.72

1

TI-6AI-4V

15.00

S1BRS3

retained for mua components

1.4

1

TI-6AI-4V

15.00

S1BDTRS

retained long transfer

1.72

1

TI-6AI-4V

15.00

S1BDTRSA

retained long transfer mua

1.4

1

TI-6AI-4V

15.00

- 57 -

HEALING SCREWS code S1BN3530HC S1BN3545HC S1BN3560HC

ø mm

h mm

quantity

material

price (€)

3.5 3.5 3.5

3 4.5 6

1 1 1

TI-6AI-4V TI-6AI-4V TI-6AI-4V

25.00 25.00 25.00

quantity

material

price (€)

1

TI-6AI-4V

21.00

ANALOG code

S1BNIA

IMPRESSION DIRECT TRANSFERS code

S1BNDT35

screw S1BDTRS included

ø mm

quantity

material

price (€)

3.5

1

TI-6AI-4V

35.00

- 58 -

IMPRESSION DIRECT TRANSFERS • STRAIGHT ABUTMENTS code

description

screw S1BRS1 included

ø mm

quantity

material

price (€)

3.5

1

TI-6AI-4V

60.00

S1BN135ITC

ITC

indirect transfer cap

S1BN1A35

mount | transfer | abutment

5

3.5

1

PEEK TEMPORARY STRAIGHT ABUTMENT code

S1BN1P35

20.00

TI-6AI-4V

55.00

screw S1BDTRS included

ø mm

quantity

material

price (€)

3.5

1

PEEK MED.

60.00

- 59 -

STRAIGHT ABUTMENTS WITH FRICTION FIT code

description

S1BN135F

S1BN1145F S1BN1345F

screw S1BRS1 included

ø mm

h mm

3.5

anatomic anatomic

4 4

1 3

quantity

material

price (€)

1

TI-6AI-4V

65.00

1 1

TI-6AI-4V TI-6AI-4V

75.00 75.00

STRAIGHT ABUTMENTS WITH FRICTION FIT

screw S1BRS1 included

code

angle

ø mm

S1BN235F

20°

S1BN214F

17° anatomic

4

S1BN234F

17° anatomic

4

h mm

quantity

material

price (€)

1

TI-6AI-4V

75.00

1

1

TI-6AI-4V

75.00

3

1

TI-6AI-4V

75.00

3.5

- 60 -

CASTABLE ABUTMENTS

screw S1BRS1 included

code

description

ø mm

quantity

material

price (€)

S1BN3GA35

gold base castable

4

1

POM-C/AU&PGM*

110.00

S1BN3PC35

plastic castable

3.5

1

POM-C

29.00

S1BN3PCR35

plastic castable no ex

3.5

1

POM-C

29.00

* Gold alloy AU60% PD15% PT24,9% IR0,1% AU e PGM100%. Melting range C° 1350/1460. Coefficient of elasticity GPa 110 Proof stress MPa 450-720. Extensibility %18-12. Breaking load MPa 580-810. Hardness Vickers HV5/30 105-205-230.

STRAIGHT MULTI UNIT ABUTMENTS (multi unit abutment) code S1BN41 S1BN42 S1BN44

screw S1BRS2 included

ø mm

h mm

quantity

material

price (€)

5 5 5

1 2 4

1 1 1

TI-6AI-4V TI-6AI-4V TI-6AI-4V

55.00 55.00 55.00

- 61 -

COMPONENTS FOR MUA (multi unit abutment)

*screw S1BRS3 included | **screw S1BDTRSA included

code

description

quantity

material

price (â‚Ź)

S1BHCSRA

healing cup*

1

POM-C

25.00

S1BDTCSRA impression direct transfer with long screw**

1

TI-6AI-4V

35.00

S1BITCSRA

impression transfer indirect*

1

TI-6AI-4V

35.00

S1BIASRA

analog

1

TI-6AI-4V

21.00

S1BTTA

temporary abutment*

1

TI-6AI-4V

45.00

S1BPCC

plastic castable*

1

POM-C

29.00

- 62 -

BALL ABUTMENTS

cah e calt included

code S1BN61 S1BN62 S1BN64

ø mm

h mm

quantity

material

price (€)

4 4 4

1 2 4

1 1 1

TI-6AI-4V TI-6AI-4V TI-6AI-4V

45.00 45.00 45.00

quantity

material

price (€)

code

description

CAH

cap attachment housing (containment ring)

2

TI-6AI-4V

30.00

CALT

cap attachment liner (standard retention)

2

NYLON

15.00

- 63 -

EQUATOR • COMPLETE PACKAGE (abutments, rings, caps) code S1BN130-0 S1BN130-1 S1BN130-2 S1BN130-3 S1BN130-4 S1BN130-5 S1BN130-6 code

description

144AE

h mm

quantity

material

price (€)

0.5 1 2 3 4 5 6

1 1 1 1 1 1 1

TIN TIN TIN TIN TIN TIN TIN

115.00 115.00 115.00 115.00 115.00 115.00 115.00

quantity

material

price (€)

analog for Equator®

2

AI

38.00

044CAIN

indirect impression tear pin for Equator®

2

AI

25.00

100PD

protective disk

10

EVA

7.00

- 64 -

SPARE PARTS: RINGS AND CUPS code

description

quantity

material

price (â‚Ź)

141CAE

inox container for cups

2

SURG. STEEL

20.00

140CEG

yellow, extrasoft retention

4

TEFLON

28.00

140CER

pink, soft retention

4

TEFLON

28.00

140CET

transparent, standard retention

4

TEFLON

28.00

140CEV

violet, strong retention

4

TEFLON

28.00

- 65 -

ø 3.7

ø 4.1

ø 4.7

stand at 90° of the abutment top view

bony ridge line

Material Connection Diameter Platform Diameter Heights

Ti-Gr.4 esternal hex 2.7 mm 4.1 mm 3.7 | 4.1 | 4.7 mm 6 | 8 | 10 | 11.5 | 13 | 16 | 18 mm - 66 -

Eh

3.7

h 8 | 10 | 11.5 | 13 | 16 mm

4.1

- 67 -

4.7

h 6 | 8 | 10 | 11.5 | 13 | 16 mm

3.7

4.1

4.7

Letter a b c d e f

Description neck height + platform switching apical core width apical coil width core coronal width core coil width maximum implant width

Measure [mm] 0.7 2.25 3 3.1 3.7 4.1

Letter a b c d e f

Description neck height + platform switching apical core width apical coil width core coronal width core coil width maximum implant width

Measure [mm] 0.7 2.60 3.35 3.45 4.05 4.1

Letter a b c d e f

Description neck height + platform switching apical core width apical coil width core coronal width core coil width maximum implant width

Measure [mm] 0.7 3.25 4 4.1 4.65 4.1

- 68 -

3.7

a

4.1

4.7

a

a

b

b

b

c

c

c

d

d

d

e

e

e

f

f

f

- 69 -

SHAPE 1EHc MACHINED NECK code

ø 4.1 mm •

2.7 mm • screw S1EHCS included

ø mm

h mm

quantity

material

price (€)

S1EH378C S1EH3710C S1EH3711C S1EH3713C S1EH3716C

3.75 3.75 3.75 3.75 3.75

8 10 11.5 13 16

1 1 1 1 1

TI GR4 TI GR4 TI GR4 TI GR4 TI GR4

125.00 125.00 125.00 125.00 125.00

S1EH416C S1EH418C S1EH4110C S1EH4111C S1EH4113C S1EH4116C

4.1 4.1 4.1 4.1 4.1 4.1

6.5 8 10 11.5 13 16

1 1 1 1 1 1

TI GR4 TI GR4 TI GR4 TI GR4 TI GR4 TI GR4

125.00 125.00 125.00 125.00 125.00 125.00

S1EH476C S1EH478C S1EH4710C S1EH4711C S1EH4713C S1EH4716C

4.7 4.7 4.7 4.7 4.7 4.7

6.5 8 10 11.5 13 16

1 1 1 1 1 1

TI GR4 TI GR4 TI GR4 TI GR4 TI GR4 TI GR4

125.00 125.00 125.00 125.00 125.00 125.00

- 70 -

SURGICAL | PROSTHETIC SCREWS code

description

S1EHCS

surgical

S1EHRS1

included in the implant and prosthetic packaging - available as spare parts

ø mm

thread mm

quantity

material

price (€)

4.8

2

1

TI-6AI-4V

15.00

retained abutments

2

1

TI-6AI-4V

15.00

S1EHRS2

retained mua

2

1

TI-6AI-4V

15.00

S1EHRS3

retained for mua components

1.4

1

TI-6AI-4V

15.00

S1EHDTRS

retained long transfer

2

1

TI-6AI-4V

15.00

S1EHDTRSA

retained long transfer mua

1.4

1

TI-6AI-4V

15.00

- 71 -

HEALING SCREWS code S1EH4820HC S1EH4830HC S1EH4840HC S1EH4855HC S1EH4870HC

ø mm

h mm

quantity

material

price (€)

4.8 4.8 4.8 4.8 4.8

2 3 4 5.5 7

1 1 1 1 1

TI-6AI-4V TI-6AI-4V TI-6AI-4V TI-6AI-4V TI-6AI-4V

25.00 25.00 25.00 25.00 25.00

quantity

material

price (€)

1

TI-6AI-4V

21.00

ANALOG code

S1EHIA

IMPRESSION DIRECT TRANSFERS code

S1EHDT41

screw S1EHDTRS included

ø mm

quantity

material

price (€)

4.1

1

TI-6AI-4V

35.00

- 72 -

STRAIGHT TEMPORARY ABUTMENTS

screw S1EHDTRS included

code

description

ø mm

quantity

material

price (€)

S1EH1TT41

anti-rotating

4.1

1

TI-6AI-4V

45.00

S1EH1TTR41

rotating

4.1

1

TI-6AI-4V

46.00

STRAIGHT ABUTMENT

screw S1EHDTRS included

code

S1EH141

ø mm

quantity

material

price (€)

4.1

1

TI-6AI-4V

65.00

ANGLED ABUTMENTS

screw S1EHDTRS included

code

angle

S1EH215 S1EH225

15° 25°

ø mm

quantity

material

price (€)

4.1 4.1

1 1

TI-6AI-4V TI-6AI-4V

75.00 75.00

- 73 -

CASTABLE ABUTMENTS

screw S1EHTRS included

code

description

ø mm

quantity

material

price (€)

S1EH3GA

gold base castable

4.1

1

POM-C/AU&PGM*

110.00

S1EH3GAR

gold base castable no ex

4.1

1

POM-C/AU&PGM*

110.00

S1EH3PC

plastic castable

4.1

1

POM-C/AU&PGM*

29.00

S1EH3PCR

plastic castable no ex

4.1

1

POM-C/AU&PGM*

29.00

* Gold alloy AU60% PD15% PT24,9% IR0,1% AU e PGM100%. Melting range C° 1350/1460. Coefficient of elasticity GPa 110 Proof stress MPa 450-720. Extensibility %18-12. Breaking load MPa 580-810. Hardness Vickers HV5/30 105-205-230.

- 74 -

STRAIGHT MULTI UNIT ABUTMENTS (multi unit abutment) code

S1EH41 S1EH42 S1EH43

screw S1EHRS2 included

ø mm

h mm

quantity

material

price (€)

4.1 4.1 4.1

1 2 3

1 1 1

TI-6AI-4V TI-6AI-4V TI-6AI-4V

55.00 55.00 55.00

ANGLED MULTI UNIT ABUTMENTS (multi unit abutment) code

angle

S1EH5217 S1EH5317 S1EH5430 S1EH5530

17° 17° 30° 30°

screw S1EHRS2 included

ø mm

h mm

quantity

material

price (€)

4.1 4.1 4.1 4.1

2 3 4 5

1 1 1 1

TI-6AI-4V TI-6AI-4V TI-6AI-4V TI-6AI-4V

85.00 85.00 85.00 85.00

- 75 -

COMPONENTS FOR MUA (multi unit abutment) code

description

S1EHHCSRA4 healing cup* S1EHHCSRA8 healing cup*

*screw S1BRS3 included | **screw S1BDTRSA included

h mm

quantity

material

price (â‚Ź)

4 8

1 1

POM-C POM-C

25.00 25.00

S1EHDTCSRA

impression direct transfer with long screw**

1

TI-6AI-4V

30.00

S1EHRTTA

stump provisional retentive*

1

TI-6AI-4V

45.00

S1EHIASRA

analog

1

TI-6AI-4V

21.00

S1EHTTA

temporary abutment*

1

TI-6AI-4V

45.00

S1EHPCC

plastic castable*

1

POM-C

29.00

- 76 -

BALL ABUTMENTS

cah e calt included

code S1EH62 S1EH63 S1EH64 S1EH65

ø mm

h mm

quantity

material

price (€)

4.5 4.5 4.5 4.5

2 3 4 5

1 1 1 1

TI-6AI-4V TI-6AI-4V TI-6AI-4V TI-6AI-4V

45.00 45.00 45.00 45.00

quantity

material

price (€)

code

description

CAH

cap attachment housing (containment ring)

2

TI-6AI-4V

30.00

CALT

cap attachment liner (standard retention)

2

NYLON

15.00

- 77 -

EQUATOR • COMPLETE PACKAGE (abutments, rings, caps) code S1EH130-2 S1EH130-3 S1EH130-4 S1EH130-5 S1EH130-6 S1EH130-7

code

description

144AE

h mm

quantity

material

price (€)

2 3 4 5 6 7

1 1 1 1 1 1

TIN TIN TIN TIN TIN TIN

115.00 115.00 115.00 115.00 115.00 115.00

quantity

material

price (€)

analog for Equator®

2

AI

38.00

044CAIN

indirect impression tear pin for Equator®

2

AI

25.00

100PD

protective disk

10

EVA

7.00

- 78 -

SPARE PARTS: RINGS AND CUPS code

description

quantity

material

price (â‚Ź)

141CAE

inox container for cups

2

SURG. STEEL

20.00

140CEG

yellow, extrasoft retention

4

TEFLON

28.00

140CER

pink, soft retention

4

TEFLON

28.00

140CET

transparent, standard retention

4

TEFLON

28.00

140CEV

violet, strong retention

4

TEFLON

28.00

- 79 -

ø 3.7

ø 4.1

ø 4.7 45° angled for a guided insertion of the abutment with 8°of conical connection top view

bony ridge line

Material Connection Diameter Platform Diameter Heights

Ti-Gr.4 octagonal internal 3.1 mm 4.8 mm 3.7 | 4.1 | 4.7 mm 4| 6 | 8 | 10 | 11.5 | 13 | 16 mm - 80 -

T

3.7

h 8 | 10 | 11.5 | 13 | 16 mm

4.1

- 81 -

4.7

h 4| 6 | 8 | 10 | 11.5 | 13 | 16 mm

3.7

4.1

4.7

Letter a b c d e f

Description neck height + platform switching apical core width apical coil width core coronal width core coil width maximum implant width

Measure [mm] 2.5 2.25 3 3.1 3.7 4.8

Letter a b c d e f

Description neck height + platform switching apical core width apical coil width core coronal width core coil width maximum implant width

Measure [mm] 2.5 2.60 3.35 3.45 4.05 4.8

Letter a b c d e f

Description neck height + platform switching apical core width apical coil width core coronal width core coil width maximum implant width

Measure [mm] 2.5 3.25 4 4.1 4.65 4.8

- 82 -

3.7

a

4.1

a

4.7

a

b

b

b

c

c

c

d

d

d

e

e

e

f

f

f

- 83 -

SHAPE 1T TISSUE LEVEL code

ø 4.8 mm •

3.1 mm • screw S1TCS and abutment S1TA50 included

ø mm

h mm

quantity

material

price (€)

S1T378 S1T3710 S1T3711 S1T3713 S1T3716

3.75 3.75 3.75 3.75 3.75

8 10 11.5 13 16

1 1 1 1 1

TI GR4 TI GR4 TI GR4 TI GR4 TI GR4

140.00 140.00 140.00 140.00 140.00

S1T414 S1T414 S1T414 S1T414 S1T414 S1T414 S1T414

4.1 4.1 4.1 4.1 4.1 4.1 4.1

4.5 6.5 8 10 11.5 13 16

1 1 1 1 1 1 1

TI GR4 TI GR4 TI GR4 TI GR4 TI GR4 TI GR4 TI GR4

140.00 140.00 140.00 140.00 140.00 140.00 140.00

S1T474 S1T476 S1T478 S1T4710 S1T4711 S1T4713 S1T4716

4.7 4.7 4.7 4.7 4.7 4.7 4.7

4.5 6.5 8 10 11.5 13 16

1 1 1 1 1 1 1

TI GR4 TI GR4 TI GR4 TI GR4 TI GR4 TI GR4 TI GR4

140.00 140.00 140.00 140.00 140.00 140.00 140.00

- 84 -

SURGICAL | PROSTHETIC SCREWS code

description

S1TCS

surgical

S1TRS1

retained abutments

included in the implant and prosthetic packaging • available as spare parts

ø mm

thread mm

quantity

material

price (€)

4.8

2

1

TI-6AI-4V

15.00

2

1

TI-6AI-4V

15.00

ANALOG code

quantity

material

price (€)

S1TIA

1

TI-6AI-4V

21.00

STRAIGHT ABUTMENTS code S1T1A50 S1T140

screw S1TRS1 included

description mount | transfer | abutment abutment

ø mm

quantity

material

price (€)

5

1

TI-6AI-4V

55.00

4.5

1

TI-6AI-4V

75.00

- 85 -

ANGLED ABUTMENTS

screw S1TRS1 included

code

description

S1T240

abutment 17°

ø mm

quantity

material

price (€)

4.5

1

TI-6AI-4V

85.00

econometric connection with octagon

CASTABLE ABUTMENTS

screw S1TRS1 included

code

description

ø mm

quantity

material

price (€)

S1T3PC45

plastic castable

5

1

POM-C

29.00

S1T3PCR45

plastic castable no ex

5

1

POM-C

29.00

- 86 -

BALL ABUTMENTS

cah e calt included

code

ø mm

h mm

quantity

material

price (€)

S1T60 S1T61 S1T62

4.5 4.5 4.5

0 1 2

1 1 1

TI-6AI-4V TI-6AI-4V TI-6AI-4V

45.00 45.00 45.00

quantity

material

price (€)

code

description

CAH

cap attachment housing (containment ring)

2

TI-6AI-4V

30.00

CALT

cap attachment liner (standard retention)

2

NYLON

15.00

- 87 -

EQUATOR • COMPLETE PACKAGE (abutments, rings, caps) code S1T130-0 S1T130-1 S1T130-2 S1T130-3 S1T130-4 S1T130-5 S1T130-6 code

description

144AE

h mm

quantity

material

price (€)

0.5 1 2 3 4 5 6

1 1 1 1 1 1 1

TIN TIN TIN TIN TIN TIN TIN

115.00 115.00 115.00 115.00 115.00 115.00 115.00

quantity

material

price (€)

analog for Equator®

2

AI

38.00

044CAIN

indirect impression tear pin for Equator®

2

AI

25.00

100PD

protective disk

10

EVA

7.00

- 88 -

SPARE PARTS: RINGS AND CUPS code

description

quantity

material

price (â‚Ź)

141CAE

inox container for cups

2

SURG. STEEL

20.00

140CEG

yellow, extrasoft retention

4

TEFLON

28.00

140CER

pink, soft retention

4

TEFLON

28.00

140CET

transparent, standard retention

4

TEFLON

28.00

140CEV

violet, strong retention

4

TEFLON

28.00

- 89 -

SHAPE MINI

WITH ANALOG AND CASTABLE

material TI-6AI-4V

- 90 -

ø 2,7

h 16

h 13

- 91 -

h 11.5

h 10

SURGICAL AND PROSTHETIC INSTRUMENTS

- 92 -

- 93 -

DRILL

short (S); long (L)

code

description

LD

lance

D23S D23L

pilot pilot

D2428S D2428L D2833S D2833L D3338S D3338L D3844S D3844L

ø mm

quantity

material

price (€)

2

1

SURG. STEEL.

45.00

2.3 2.3

1 1

SURG. STEEL. SURG. STEEL.

65.00 65.00

1 1 1 1 1 1 1 1

SURG. STEEL. SURG. STEEL. SURG. STEEL. SURG. STEEL. SURG. STEEL. SURG. STEEL. SURG. STEEL. SURG. STEEL.

65.00 65.00 65.00 65.00 65.00 65.00 65.00 65.00

2.4 | 2.8 2.4 | 2.8 2.8 | 3.3 2.8 | 3.3 3.3 | 3.8 3.3 | 3.8 3.8 | 4.4 3.8 | 4.4

h mm

32 39 32 39 32 39 32 39

DRILL EXTENDER code

DE

- 94 -

quantity

material

price (€)

1

SURG. STEEL.

35.00

DRILL STOPS code

ø mm

h mm

quantity

material

price (€)

DS63337 DS64147 DS83337 DS84147 DS103337 DS104147 DS113337 DS114147 DS133337 DS134147

33 | 37 41 | 47 33 | 37 41 | 47 33 | 37 41 | 47 33 | 37 41 | 47 33 | 37 41 | 47

6 6 8 8 10 10 11.5 11.5 13 13

1 1 1 1 1 1 1 1 1 1

SURG. STEEL. SURG. STEEL. SURG. STEEL. SURG. STEEL. SURG. STEEL. SURG. STEEL. SURG. STEEL. SURG. STEEL. SURG. STEEL. SURG. STEEL.

35.00 35.00 35.00 35.00 35.00 35.00 35.00 35.00 35.00 35.00

COUNTERSINK code CSD37 CSD41 CSD47

ø mm

quantity

material

price (€)

3.7 4.1 4.7

1 1 1

SURG. STEEL. SURG. STEEL. SURG. STEEL.

85.00 85.00 85.00

- 95 -

TAPS code

TAP33 TAP37 TAP41 TAP47

ø mm

quantity

material

price (€)

3.3 3.7 4.1 4.7

1 1 1 1

SURG. STEEL. SURG. STEEL. SURG. STEEL. SURG. STEEL.

85.00 85.00 85.00 85.00

quantity

material

price (€)

1

SURG. STEEL.

15.00

PARALLEL PIN code

PP

- 96 -

IMPLANT DRIVERS

short (S); long (L)

code

description

HD20

for straight mua (hex)

HD21S HD21L

ø mm

h mm

quantity

material

price (€)

2

1

SURG. STEEL.

45.00

for S1BN (hex) for S1BN (hex)

2.1 2.1

1 1

SURG. STEEL. SURG. STEEL.

45.00 45.00

HD25S HD25L

for S1B (hex) for S1B (hex)

2.5 2.5

1 1

SURG. STEEL. SURG. STEEL.

45.00 45.00

HD31S HD31L

for S1T (octagon) for S1T (octagon)

3.1 3.1

1 1

SURG. STEEL. SURG. STEEL.

45.00 45.00

08926 08927

for Locator® for Locator®

1 1

SURG. STEEL. SURG. STEEL.

65.00 65.00

15 21

- 97 -

LATCH-LOCK IMPLANT DRIVERS

short (S); long (L)

code

description

ø mm

HDH20

for straight mua (hex)

2

HDH21S HDH21L

for S1BN (hex) for S1BN (hex)

2.1 2.1

HDH25S HDH25L

for S1B (hex) for S1B (hex)

2.5 2.5

760CE

per Equator® (quadrato)

1.25

h mm

quantity

material

price (€)

1

SURG. STEEL.

45.00

25 30

1 1

SURG. STEEL. SURG. STEEL.

45.00 45.00

25 30

1 1

SURG. STEEL. SURG. STEEL.

45.00 45.00

1

SURG. STEEL.

45.00

quantity

material

price (€)

1

SURG. STEEL

95.00

TORQUE WRENCH code

description

TW

10-40 N/cm2

- 98 -

TORQUE NOT WRENCH code

description

R

10-40 N/cm2

quantity

material

price (€)

1

SURG. STEEL

95.00

ø mm

quantity

material

price (€)

PROSTHETIC DRIVERS code

description

THDS

manual short

1.25

1

SURG. STEEL.

45.00

THDL

manual long

1.25

1

SURG. STEEL.

45.00

ø mm

quantity

material

price (€)

1.25

1

SURG. STEEL.

45.00

LATCH-LOCK HEX DRIVER code

THDD

- 99 -

MANUAL IMPLANT DRIVERS

short (S); long (L)

code

description

quantity

material

price (€)

IDS

short

1

SURG. STEEL

45.00

IDL

long

1

SURG. STEEL

65.00

08393

for Locator®

1

SURG. STEEL

95.00

quantity

material

price (€)

1

SURG. STEEL

95.00

REMOVAL TOOL FOR ABUTMENT code

description

TRT

removal tool for abutment

- 100 -

PROSTHETIC DRIVERS

short (S); long (L)

code

description

ø mm

h mm

quantity

material

price (€)

MDS

hex tapered short

1.25

23

1

SURG. STEEL.

45.00

MDL

hex tapered short

1.25

29

1

SURG. STEEL.

45.00

774CQ

Equator® square screw driver

1.25

1

SURG. STEEL.

45.00

code

description

quantity

price (€)

SK-C* SK-B*

surgical kit complete surgical kit base

1 1

2.500.00 1.500.00

1

250.00

SURGICAL KIT

*for the composition of the surgical kit view the page 19 and 21

SK-TRAY

surgical kit tray

- 101 -

ILLUSTRATIVE LEAFLET FOR THE iRES SHAPE1 IMPLANT SYSTEM - 102 -

Product characteristics The shape1 implant system by I-RES S.r.l. offers the dentist a wide choice of titanium implant configurations that differ in diameter, height and possibility of surgical positioning A) submerged/bone level, B) transmucose/tissue level, and various prosthetic components for the different rehabilitation procedures.

Indications for use The shape1 implant system is indicated for surgical treatment in the upper or lower jaw for the partial or total replacement of teeth in patients who have lost part or all of their teeth. The implant to be used must be chosen by the medical personnel based on the medical history and on the subsequent surgical and prosthetic plan required for each individual patient. The shape1 implant is delivered in sterile packs and the operator must pay

great attention when positioning it in the oral cavity, so that the implant does not come in contact with elements that could alter the surface, hindering the healing processes, so all manoeuvres must be performed in an environment suitable for surgical activities. The shape1 implant system has a series of dedicated surgical instruments for its implant lines, useful for the nontraumatic preparation of the site that is to receive the implant, and instruments designed for extracting the implant from the blister and transporting it to the mouth for insertion. Each blister containing the implant is provided with a closing screw, useful for sealing the internal part of the implant after it has been inserted in the mandibular or maxillary bone.

Contraindications Do not use shape1 implants in - 103 -

patients who have a scarce amount of bone suitable to guarantee the primary stability of the implant in the first phase of insertion, in patients with poor oral hygiene, smokers, with uncontrolled systemic pathologies and blood disorders. In addition to the normal contraindications for general surgery, the conditions described above can have a negative influence on the partial or total integration of the implant.

Warnings To use the shape1 implant system

by I-RES S.r.l. the dentist must know the general surgical and prosthetic techniques and the specific techniques for shape1 implants, following the indications of the surgical protocol and specific training courses. An incorrect choice of implant and surgical technique can be prejudicial to the success of the operation, causing the loss of

the implant and of the surrounding bone. No implant must be used that has been used previously, or that has come in contact with the organic elements of third parties. The sterility of the implant is guaranteed by the sealed packaging and by correct storage in controlled dry environments; packages that are not intact or damaged are prejudicial to the use of the implant. For product traceability it is important to keep the batch number marked on the implant package and on the adhesive labels to be found in the same package. For the same reason it is recommended that the dentist keep as long as possible his patients’ medical files, in which he has a record of their medical history, treatment plans, types of operations and prosthetic rehabilitations performed and everything that can be useful for the patient’s medical history. The use of non-original

I-RES instruments is not advised, as is the failure to follow the indications for inserting the shape1 implant and the respective prosthetic components, because they have been designed to obtain the best result; consequently I-RES S.r.l. does not accept any responsibility for the failure to follow the indications in the instruction leaflet. shape1 implants must be inserted with a maximum torque ofo 50 Ncm, exceeding this force could be prejudicial to the precision of connection with the subsequent prosthetic part. The shape1 implant system includes in its range some implants with very small diameters Ă˜ 3.3 which must not be used in diatoric areas or where there is great masticatory stress, but only for aesthetic purposes because they are not designed to bear heavy masticatory loads.

- 104 -

Collateral effects The known possible collateral effects are the partial or total failure of osseointegration, with consequent loss of the prosthetic function for which the implant system is intended, pain and transient paresthesia, fracture due to excessive load on the implant system, post or prosthesis.

Pre-operative planning The careful study and assessment of patients who are candidates for implant-prosthetic therapy is of fundamental importance. Physical, instrumental, and radiological examinations and the study of models allow the dentist to make the best diagnosis and consequent therapy. The preparation of the patient for surgical implant therapy and the preparation of the operating room must be given the same care

and attention as general surgery; the preparation of the implant site using dedicated drills with controlled revolutions, cooled with saline solution, these are all indispensable conditions for implant therapy.

Surgical complications Implant surgery operations may lead to some complications that are usually temporary and restricted to the area of operation, such as inflammation, paresthesia, haematoma; there may also be injuries to nerves, to vascular complexes and the membrane of the maxillary sinus. Bone sequestration has rarely occurred.

implants are surface treated to improve osseointegration by means of sandblasting followed by double acid-etching. Decontamination is performed with cold Argon plasma followed by packaging in a cleanroom, for the final sterilisation phase with gamma or beta rays. The pack containing the implant and the respective cover screw must be opened in a sterile environment in the phases of surgical implant therapy.

Symbols on the package Fabbricante - Manufactures iRES S.r.l.

Reliable, Efficient, Safe Via Correggio, 3 24149 Milano [Italia] info@i-res-group.com www.i-res-group.com CE Mark according to standard MDD 93/42/EEC Batch number Use by Sterilized by gamma or beta rays Do not reuse Do not restirilize Follow the instructions given in the illustrative leaflet

Materials and packaging

Do not expose to direct sunlight

The shape1 implant system is made of commercially pure grade 4 titanium (ASTM F67) and grade 5 titanium alloy (ASTM F136). shape1

Do not expose to rain and keep in an environment free from damp Do not use if the packaging is damage

- 105 -

ILLUSTRATIVE LEAFLET FOR iRES SHAPE1 PROSTHETIC COMPONENTS - 106 -

Product characteristics Healing screws. The healing screw is a device used by the dentist to keep the oral mucosa pervious in the vicinity of the implant previously inserted. Once the soft tissues have healed, this will allow the dentist to perform the subsequent manoeuvres for prosthetization. The healing screws are made of grade 5 titanium.

Transfer. The transfer in grade 5 titanium is the instrument that allows the transfer from the mouth to a model of the information needed for the prosthetic connection and for making the respective prosthesis.

There are two types of transfer: “closed tray and open tray�, and they are all composed of two parts (a screw and a repositioner).

After being inserted in the implant and secured to it with the screw,

the transfer is ready to take the impression in the mouth.

Analog. The analog made of grade 5 titanium has the function of reproducing the internal characteristics of the implant and it must be securely fixed to the transfer. Once joined, the model can be cast.

Straight, angled and millable posts. They are made of grade 5 titanium; they have different shapes depending on the characteristics they have to satisfy, they are used mostly for prosthetic rehabilitations of bridges or crowns. The choice of the device that must be connected to the analog in the first phase is dictated by the clinical and processing decisions, which are at the discretion of the dentist and the

- 107 -

dental technician.

Plastic posts. Plastic posts may be divided into two families, one for using directly in the oral cavity, appropriately modified and connected to the post to support temporary prostheses, one for the transformation of plastic posts into metal posts by the dental technician, with processing characteristics that are at the discretion of the dentist and the dental technician.

Gold Bases. These are components made of gold alloy and allow the creation of customised posts using overcasting techniques.

Ball attachments. Ball attachments are made of grade 5 titanium and, once fixed to the implants, they are able to act as an anchorage by means of special attachments to the

patient’s mobile prosthesis.

Indications for use The I-RES implant-prosthetic system is intended for use in the oral cavity and is provided with useful components to enable the dentist and the dental technician to prosthetically complete the operation begun by the dentist by inserting the implant in the patient.

The I-RES implant-prosthetic system completes the line of I-RES dental implants and the respective I-RES instruments.

Contraindications Do not use I-RES products on patients who have allergies to the materials of which the component is made.

The use of I-RES components in patients who have metabolic and periodontal diseases or poor oral hygiene may be prejudicial to the success of the work, as may prosthetic constructions not in line with international standards. The lack of periodic controls, which the patient must undergo with his dentist after prosthetisation, may compromise the life of the implantprosthetic system.

Warnings I-RES prosthetic components are reserved for use by personnel with knowledge of the subject.

I-RES points out that alterations to the implant/post connections may be prejudicial to the success of the work, as may the failure to use original components. When

- 108 -

using prosthetic components it is important to follow the instructions given by the dentist and the dental technician. When using prosthetic components in the oral cavity it is important to respect the final tightening value which must be between 20 and 30 Ncm, as better specified in the catalogue.

Collateral effects Today there are no known collateral effects in the use of I-RES components that can endanger the patient’s health.

Prosthetic planning The choice of the I-RES components to be used for the case is the specific responsibility of the dentist and of the dental technician, depending on their requirements.

Materials and packaging All I-RES prosthetic components are packed in such a way as to be immediately identifiable, once removed from their pack; it is important for the operator to pay great attention in identifying them to avoid changes of position during work.

It is useful to make note of the material batch used on the patient’s file, for the purpose of traceability.

Whether it has been processed or not, before inserting the I-RES prosthetic component in the oral cavity it is of fundamental importance that it be washed and sterilised. Some I-RES components are single-use, so intended for only one patient.

Symbols on the package Fabbricante - Manufactures iRES S.r.l.

Reliable, Efficient, Safe Via Correggio, 3 24149 Milano [Italia] info@i-res-group.com www.i-res-group.com CE Mark according to standard MDD 93/42/EEC Batch number Use by

Do not reuse Follow the instructions given in the illustrative leaflet Do not expose to direct sunlight Do not expose to rain and keep in an environment free from damp Do not use if the packaging is damage Unsterile

- 109 -

INSTRUCTIONS FOR THE USE OF iRES SHAPE1 ROTARY INSTRUMENTS - 110 -

Product description DENTAL DRILLS, produced by I-RES Srl, must be used as tools to perforate the bone. The diameters to be used, the lengths and the drilling sequence (number of drills to be used) are the sole choice and decision of the dentist, depending on the surgical protocol that must be followed. The maximum recommended speed is 800 rpm with saline solution applied directly on the drill to assist cooling. a) The sole purpose of the initial precision drill is to incise the cortical bone in a very precise point where it will later be drilled. b) The helical drills have laser markings for reference which identify the depth to be reached.

Of course, in the use of this type of drill the manual skill and experience of the dental surgeon are extremely

important, especially for stopping at the chosen depth.

Countersinks are used when it is necessary to widen the initial part of the hole made to adapt the shape that of the neck of the implant to be inserted. The maximum recommended speed is 300 rpm with saline solution applied directly on the drill to assist cooling.

Bone taps: in particularly dense bone (type I), before insertion it is advisable to use a bone tap with the same profile as the implant to be inserted. The bone tap has a greater cutting power than the implant, allowing the site to be prepared with reduced trauma. The maximum recommended speed is 30 rpm with saline solution applied directly on the bone tap to assist cooling.

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Materials used All I-RES Srl drills are made of medical grade steel and undergo hardening heat treatment. The maximum recommended number of uses of the devices is 25 times.

Warnings and general precautions It is fundamental to respect the surgical protocol that establishes the diameters, lengths and the sequence of use. The operator is fully responsible for any uses other than those indicated. Check that the drills to be used are in good condition, already cleaned and sterilised. Check that the drills are in good condition and have not been used more than 25 times. Before using them, check that the handpiece holds the drills perfectly secure and that they rotate in the correct direction. Ensure that there is adequate irrigation. The

application of leverage during drilling could cause breakage of the drill, the handpiece, or the bone walls on which you are working. During drilling always exert alternating pressure, using the intermittent drilling technique. Always check that the laser marking that indicates diameter and length is clearly visible. Any eccentricity or lack of straightness in the drill could result in an oversized hole. Wear eye protection, to protect against particles that may be ejected.

Failure to follow these indications may lead to the onset of infections and complications for the implant and, more generally, for the patient.

More detailed information on the use of the medical device can be found in the Surgical Protocol. If you do not have a copy, request one from your distributor or directly from the manufacturer.

Symbols on the package Fabbricante - Manufactures iRES S.r.l.

Reliable, Efficient, Safe Via Correggio, 3 24149 Milano [Italia] info@i-res-group.com www.i-res-group.com

CE Mark according to standard MDD 93/42/EEC

Batch number

Follow the instructions given in the illustrative leaflet

Do not expose to direct sunlight

CLEANING | STERILISATION | STORAGE

Do not expose to rain and keep in an environment free from damp

The medical devices are supplied NOT STERILE.

Do not use if the packaging is damage

Before use, all rotary devices must be cleaned, disinfected and sterilised.

Unsterile

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PARTNERSHIP To complete their range dedicated to oral surgery, I-RES have recently reached partnership agreements with W&H Italia S.r.l., Mectron, Garda Laser for the sale to their customers of surgical instruments such as micromotors, systems for piezoelectric surgery and lasers for use in dentistry. Our agents will supply all the technical and commercial information, as well as leaflets, product brochures and scientific documentation.

SUPPORT Lifetime guarantee on the implants if supported by certification (request on headed paper, patient chart supplied by the company to be compiled in all fields, lost implant). Replacement at a 50% discount of implants opened due to incorrect assessment of use, or which have been accidentally dropped. Guaranteed 24-hour delivery. Possibility of financing at zero interest rate.For information, call the number 0363 688 016/8 or write to the email address info@ires-group.com Visit our site and purchase on-line:www.i-res-group.com.

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CERTIFICATION I-RES Srl is a company with quality management system according to UNI EN ISO 9001 and UNI EN ISO 13485 whose quality standards are subjected to strict controls by the Certification Authority.

FDA certification in progress for approval for free sale in the United States.

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Brochure_Shape1_RevC - 09/2014

iRES S.r.l. • via Correggio 3 • 20149 Milano [Italia] t. [+39] 035 27.07.43 • f. [+39] 035 22.59.64 info@i-res-group.com • www.i-res-group.com