Catalogo de Biomateriales Mis 2014

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MC-UNO08 Rev.1 MC-BRGEN Rev.3

MIS Quality System complies with international quality

®

standards: ISO 13485:2003 - Quality Management System for Medical Devices, ISO 9001: 2008 – Quality Management System and CE Directive for Medical Devices 93/42/EEC. Please note not all products are registered

MIS Implants Technologies Ltd. www.mis-implants.com

0483

ISO 9001:2000 ISO 13485:2003

or available in every country/region.

Authorized European Representative: MIS Germany, Paulinenstraße 12a, 32427 Minden, GERMANY

© MIS Corporation. All rights reserved. © MIS Corporation. All Rights Reserved.


Toll Free 1-(866) 797 1333 MC-UNO08 Rev.1 MC-BRGEN Rev.3 TM

An Expanded Range of Regenerative Solutions by

MAKE IT SIMPLE


P.4-5 P.6-7 P.8-9 P.10-11 P.12-13 P.14-15 P.16-17 P.18-19 P. 20-21

MIS Warranty: MIS exercises great care and effort in maintaining the superior quality of its products. All MIS products are guaranteed to be free from defects in material after using it according to the directions, the defective product will be replaced. Warning: Only a licensed dentist should use these products. The images contained in this promotional material is for illustration purposes only and is subject to change.


Table of contents. Introduction 4BONE XBM - Anorganic Bovine Bone Matrix TM

4BONE BCH - Synthetic Bone Substitute TM

BONDBONE 速 - Bonding Graft Material 4BONE RCB - Resorbable Conforming Barrier Membrane TM

4BONE RSB - Resorbable Collagen Barrier Membrane TM

4BONE RCM - Resorbable Collagen Membrane TM

4BONE PLUG & TAPE- Resorbable Collagen Wound Dressing TM

4BONE Range Packaging TM


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Optimal volumes and quality of hard and soft tissue are required to satisfy the goals of oral rehabilitation and implant dentistry. MIS offers a range of regenerative materials for dental use aimed at providing solutions for a wide variety of clinical needs. MIS regenerative products are available in varying volumes and sizes for simple and easy delivery directly to the surgical site. High quality engineering and manufacturing processes ensure safety of all MIS products. The selection of regenerative solutions offered by MIS allows clinicians to choose the precise products necessary to obtain the optimal surgical outcome.

Š MIS Corporation. All rights reserved.


Toll Free 1-(866) 797 1333


4BONETM XBM Bovine Bone Matrix

Timeline for implant placement* (months):

0

2

4

6

8

10

12

4BONE XBM is an anorganic bovine bone mineral matrix for use in guided bone regeneration in periodontal defects and dental implant procedures. Manufacturer: Collagen Matrix Inc. Oakland, NJ, USA

ORDERING INFORMATION 4B-X2505 - XBM vial 0.5cc, granule size: 0.25-1mm 4B-X2510 - XBM vial 1.0cc, granule size: 0.25-1mm 4B-X2525 - XBM vial 2.5cc, granule size: 0.25-1mm 4B-X2540 - XBM vial 4.0cc, granule size: 0.25-1mm 4B-X1010 - XBM vial 1.0cc, granule size: 1-2mm 4B-X1025 - XBM vial 2.5cc, granule size: 1-2mm

*

implant placement, which is typically 4-6 months after implantation of a be allowed after implantation of bone graft material before placement of the

6.

to dental implant placement.


Advantages

Indications for using 4BONE XBM:

4BONE XBM is produced by the removal of all organic components from bovine bone, leaving the natural mineral component for use as an osteoconductive material to support bone regeneration. Due to its natural structure, 4BONE XBM is physically and chemically comparable to the mineralized matrix of human bone. The trabecular architecture with interconnecting macro and micro pores allows for the optimal ingrowth of new vascularity and bone at the graft site and maximizes the potential for angiogenesis.

Filling of infrabony periodontal defects

Filling of extraction sockets

Osteoconductive Composition and structure similar to that of natural human bone.

Safe

Filling of peri-implant defects

Quality and design control processes assure high standards of sterilization and safety.

Versatile May be used by itself or mixed with autogenous bone.

Ridge augmentation

Variety Available in a range of volumes and particle sizes. Sinus augmentation


4BON ETM BCH Synthetic Bone Substitute

Timeline for implant placement (months):

0

2

4

6

8

10

12

4BONE BCH is a fully synthetic bioactive bone substitute composed of chemical synthesis of 60% HA and 40% Ă&#x;-TCP. It is recommended for use as a bone augmentation material in dental implant procedures.

ORDERING INFORMATION BS-4BS01 - BCH syringe 0.5cc, granule size: 0.5-1mm BS-4BS1S - BCH tube1cc, granule size: 0.5-1mm BS-4BS25 - BCH tube 2.5cc, granule size: 1-2mm

8.

New packaging available in 2014


Advantages

Indications for using 4BONE BCH:

With its interconnected micro and macro porosity and osteoconductive properties, 4BONE BCH attracts osteogenic a guaranteed homogenous distribution and diffusion of the two phases. 4BONE BCH has optimized morphology and healing process for a wide range of bone regeneration procedures.

Periodontal defects

Ridge augmentation

Osteoconductive

Micro and macro morphology allows cell attachment and proliferation.

Filling of peri-implant defects

Safe 100% synthetic. No human or animal origin.

Easy to Use Granules are easily mixed with saline or the patient’s own blood. 0.5cc Syringe packaging enables direct delivery to the augmented site.

Sinus augmentation

Variety Available in a range of volumes and particle sizes. Bone defects


BONDBONE速 Bonding Graft Material

Timeline for implant placement (months):

0

2

4

6

8

10

12

BONDBONE is an innovative synthetic bone grafting material composed of biphasic calcium sulfate. Due to it novel engineering process, BONDBONE has excellent

handling properties. The initial pliable paste is fast setting and is not affected by the presence of blood and saliva.

ORDERING INFORMATION BS-BB005 - BONDBONE速 0.5cc, 3 Drivers BS-BB010 - BONDBONE速 1cc, 3 Drivers

New packaging available in 2014

10.


Advantages

Indications for using BONDBONE:

BONDBONE is a resorbable, osteoconductive bone grafting material taking the best qualities of hemihydrate and dihydrate calcium sulfate and combining them into one unique product. When combined with other augmentation products, BONDBONE acts as a binder to improve graft stability and to increase volume and effectiveness of the bone graft. BONDBONE can be used as a highly effective material for socket preservation procedures and the augmentation of small defects.

Ridge augmentation and sinus augmentation

Bone defects and extraction sockets

Osteoconductive Microporous structure for rapid growth factors and cells.

Effective

Extraction sites

Bioactive binder that sets in the presence of blood and saliva, facilitating predictable resorption time and increasing the percentage of vital bone.

Biocompatible 100% medical grade biphasic calcium sulfate is completely resorbable. Peri- implant defects

Easy to Use Syringe delivery and fast setting


4BON ETM RCB Resorbable Conforming Barrier Membrane

Predictable Resorption Time* (months):

0

2

3

4

6

8

10

12 *up

bovine collagen. 4BONE RCB is a fully resorbable and adaptable cell occlusive barrier used in guided bone regeneration procedures in the area of dental implants, bone defects and ridge augmentations. Manufacturer: Collagen Matrix Inc. Oakland, NJ, USA

ORDERING INFORMATION RCB: 4B-C1520 - 15x20mm RCB: 4B-C2030 - 20x30mm RCB: 4B-C3040 - 30x40mm

12.

to 3-4 months


Advantages

3-4 months

Indications for using 4BONE RCB:

4BONE RCB is a versatile resorbable barrier membrane. Upon hydration, the barrier membrane easily adapts and conforms to all surgical sites and supports healing of bone and soft tissue. 4BONE RCB can be easily trimmed and does not adhere to itself or instruments when hydrated. The optimal mechanical properties and high tensile strength of 4BONE RCB allow for easy placement and adaptability in ridge augmentation procedures due to its ability to naturally conform to the site where it is placed.

Extraction sites

Periodontal defects

Versatile Either side may be placed against bone/tissue Can be used in dry or hydrated state

Safe

Sinus augmentation

Sterile Engineered from highly

Effective Predictable resorption time (up to 3-4 months) Excellent mechanical properties Fully resorbable Guides healing of bone and surrounding tissue

Peri-implant defects

Easy to Use Highly adaptable Non-friable with excellent handling properties Easy to trim and shape

Ridge augmentation


4BON ETM RSB Resorbable Collagen Barrier Membrane

Total Resorption Time (months):

0

2

4

6

8

9

10

12 * 6-9

4BONE RSB Collagen Barrier Membrane is a bioresorbable, cell occlusive membrane a barrier membrane in guided bone regeneration procedures in the areas of dental implants, bone defects and ridge augmentations. Manufacturer: Collagen Matrix Inc. Oakland, NJ, USA

ORDERING INFORMATION RSB: 4B-S1520 - 15x20mm RSB: 4B-S2030 - 20x30mm RSB: 4B-S3040 - 30x40mm

14.

months resorption time


Advantages

Indications for using 4BONE RSB:

RSB Resorbable Collagen Barrier Membrane is the product of choice to prevent soft tissue ingrowth during healing in defects that lack bony wall support. The semi-permeable properties of 4BONE RSB permit the exchange of essential nutrients for healing, while the porosity qualities effectively hinder epithelial down growth, preventing gingiva connective tissue cell migration into the treated site. Optimal resorption time allows for sustained function during the healing process.

Extraction sites

Periodontal defects

Versatile Either side may be placed against bone/tissue Can be used in dry or hydrated state

Sinus augmentation

Safe Sterile Type I bovine collagen

Effective Total resorption time 6-9 months Ideal rigidity Semi-permeable Guides healing of bone and surrounding tissue Fully resorbable

Peri-implant defects

Easy to Use Non-friable with excellent handling properties Easy to trim and shape Ridge augmentation


4BON ETM RCM Resorbable Collagen Membrane

Total Resorption Time (months):

0

2

4

6

8

10

12

4BONE RCM Collagen Membrane is a resorbable, cell occlusive barrier used in guided bone regeneration procedures in the areas of dental implants, bone defects and ridge augmentation.

ORDERING INFORMATION RCM: BR-C1525 - 15x25mm RCM: BR-C2030 - 20x30mm RCM: BR-C3040 - 30x40mm

FDA clearance for marketing pending

16.


Advantages

Indications for using 4BONE RCM:

4BONE RCM is engineered from porcine collagen. Due to its biocompatibility and low immunogenicity, porcine collagen has been successfully used in medical and dental procedures. 4BONE RCM is easy to trim, shape and adapt to the osseous defect of bone to regenerate.

Extraction sites

Periodontal defects

Versatile Either side may be placed against bone/tissue Can be used in dry or hydrated state

Sinus augmentation

Safe Sterile Engineered from Type I & III Porcine Collagen

Effective Predictable resorption time of 4-6 months for prolonged protection and function Excellent mechanical properties Fully resorbable

Peri-implant defects

Easy to Use Easily adapted and applied to surgical site Optimal handling and high tensile strength for ease of placement and suturing Ridge augmentation


4BON ETM PLUG & 4BON ETM TAPE Wound Dressings

4BONE PLUG and 4BONE TAPE are used following oral surgical procedures to aid

and blood at the defect site. Manufacturer: Collagen Matrix Inc. Oakland, NJ, USA

ORDERING INFORMATION 4B-T0010 - TAPE 10/box. Size: 2.5cm x 7.5cm, 1mm thick

ORDERING INFORMATION 4B-P0010 - PLUG 10/box. Size: 1cm x 2cm

18.


Advantages

Indications for the management of:

4BONE PLUG and 4BONE TAPE are sterile dental wound dressings engineered from bovine Type I collagen. They protect the oral wound bed and control minor bleeding due

Oral wounds

Surgical wounds

Easy to Use Ideal for applications in minor oral wounds

Extraction sites

Effective

Supports wound healing

Safe

Supplied in individual sterile packages

Provides a matrix for wound healing

Absorbent Provides a matrix for wound healing Aids in the repair of Schneiderian Membrane


20.


4BONE RANGE PACKAGING



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