| (1) Biological Test | |
|---|---|
| Cytotoxicity Test (ISO10993-5) |
No cytotoxicity was confirmed after the cytotoxicity test on Fixture eluate. |
| Sensitization Test (ISO 10993-10) |
Red spots or edema were not observed from the contact sensitization test and no harm was confirmed against allergy or sensitization reaction. |
| Intradermal Test (ISO10993-10) |
No harm to the human body was confirmed as no red spots or edema were observed from the test that evaluates local reaction of the tissue |
| (ISO10993-6) | No inflammation or foreign body reaction was shown in histological evaluation after animal implantation and tissue- and osseo-integration conformity of the test group was confirmed. |
| Acute Toxicity Test (Parenteral- I.V route)(ISO10993-11) |
In the test, side effects are observed for 4, 24, 48 and 72 hours immediately after and after eluate injection with body weight measured immediately and 72 hours after the injection. If two or more rats die or three or more rats show body weight reduction of more than 2g, or two or more rats show convulsion, it is considered a failure of the test. Confirmed by this test. |
| (2) Mechanical Test | |
|---|---|
| Mechanical Test | Fatigue limit is measured according to the test method of ISO14081(2003) to secure reliability of the product. (Test Standard: Fatigue limit above 250N exceeding 5,000,000cycle) |
| Precision Conformity Test | The gap between contact points was measured at the average of below 5.2㎛ after tightening the tested Implant and Abutment (Test Standard: below 10㎛) |
| Rotation Angle Test | As a result of measuring the rotation angle after tightening the Implant and Abutment, it was measured at 2.56 degrees on the right and 2.50 degree on the left on average. (Test Standard: below 3 degree) |
| Detorque | As a result of measuring the degree of loosening of the implant and screw after tightening at 30Ncm, it was measured at the average of 26.29Ncm. (Test Standard: above 70% of tightening torque) |
| Rotary Shearing Strength | As a result of measuring the strength from deformation to rupture after tightening the Implant and Abutment with the Screw, no abnormality was found with the average strength of 62.89Ncm. (Limit of use: above 45Ncm) |