IS II active implant Surface test report
KYUNG HEE University dental material test and develop center
Introduction This treatment is the method that blasts HA particle(smaller than 50 ㎛) to surface of machined implant for making roughness. And then, it does acid etching. Due to Acid ingredient to surface of implant, it makes micro pore in macro pore, so that contact area with bone is larger, and facilitate cell activation.
This treatment causes short treatment period, and high probability of success. Neobiotech has more than 10 years of expertise on S.L.A surface treatment
No impurities(No residual acid, No toxic) on implant surface, so, it helps safe and stable osseointegration. Other company’s implants contain a few impurities(acid, other things) on surface, but there is no impurity on Neobiotech S.L.A surface implant through perfect cleansing method.
Macro pore and Micro pore make contact area larger, and help movement of blood flow.
S.L.A surface treatment process Manufacturing → Primary Cleansing → Secondary Cleansing → Lot Test (identifying Appearance / Size , Condition of Manufacturing) → Tertiary Cleansing→ Drying Process → Surface Treatment [Blasting : → Cleansing] → The fourth Cleansing → Surface Treatment → Final cleansing (Dual cleansing)
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IS II active implant Surface test report
KYUNG HEE University dental material test and develop center
Roughness comparison
Neobiotech S.L.A surface has optical roughness compare Neobiotech Strauman
with other implant system. Straumann has long history of
Dentium
Osstem
S.L.A surface, and through undergoing many trial and error,
Upper
1.663
1.951
1.297
3.35
they found optical roughness of fixture. Now many dentists
Middle
1.969
1.906
1.441
2.599
lower
2.428
2.024
1.319
2.36
Average
2.020
1.960
1.352
2.770
think that straumann surface is best one in the world. Following below pictures, dentium Surface R.A is too low, it’s almost same average with R.B.M. And osstem surface
(R.A Comparison data)
is too rough, this also is not good for osseointegration.(First time, straumann surface R.A was above 2.5 ㎛, but they
decreased R.A as 2.0 ㎛). Straumann R.A is 1.960㎛ and Neobiotech S.L.A R.A is similar to Straumann.(2.020㎛)
NEOBIOTECH – SLA Ra = 2.020 ㎛
Straumann Ra = 1.960 ㎛
Dentium Ra = 1.352 ㎛
OSSTEM Ra = 2.770㎛
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IS II active implant Surface test report
KYUNG HEE University dental material test and develop center
1. Cytotoxicity Conclusion : Cell Dissolution Range Index / Cell Dissolution Reaction Index = 0 / 0 No Toxicity from sample is observed. Test 1. Range of cell dissolution
Negative Control Group :Al2O3 disc – 0 mm
3. Local Lymph Node Assay(LLNA) Positive Control Group Polyurethane film – 3 mm
Purpose To evaluate Acute Toxicity of material which is dissolved from the medical device Conclusion : After test, there isn`t dead or reduced weight in excess of standard, therefore we judged that it doesn`t have Acute Toxicity.
Test Control Group : SLA treatment surface of Implant – 0 mm
Evaluation 1. Optical Density Value
Test 2.Cell Dissolution Probability
Evaluation 2. Optical Density Value Dissolution Probability within a range of cell dissolution : 0 %
2. Acute Toxicity(I.V Test) Purpose To evaluate Acute Toxicity of material which is dissolved from the medical device Conclusion : After test, there isn`t dead or reduced weight in excess of standard, therefore we judged that it doesn`t have Acute Toxicity.
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IS II active implant Surface test report
4. Pyrogeniciry
KYUNG HEE University dental material test and develop center
Image 3. after 48 hours
Purpose To evaluate possibility of causing pyrexy in material which can be dissolved from dental device Conclusion : No pyrexy was observed from 3 test animals for SLA Implant elution liquid. Image 4. after 72 hours
5. Intradermal Intracutaneous reaction Purpose To evaluate Intradermal Instracutaneous reaction for material which could be dissolved from medical device. Conclusion : Anything causing stimulation was not observed from SLA Implant elution liquid. Image 1. right after injecting test material < Difference of Intraderrmal reaction average score> Test animal 1.
Test animal 2.
Right after Injection (Polar Solvent, Non-polar Solvent
0.0, 0.0
0.0, 0.0
After 24 hours (Polar Solvent, Non-polar Solvent)
0.0, 0.0
0.0, 0.0
After 48 hours (Polar Solvent, Non-polar Solvent)
0.0, 0.0
0.0, 0.0
After 24 hours (Polar Solvent, Non-polar Solvent)
0.0, 0.0
0.0, 00.
Image 2. after 24 hours
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