Sargon Dental Implants

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Test Protocol for Mechanical Testing of Sargon Dental Implants.

Static Test - Five (5) sets of implant/abutment assemblies will be prepared and tested as follows:

• Implant will be installed in a vertical hole drilled in a test fixture. This hole will be about 0.002 inch larger in diameter than the implant diameter and its depth will be such that 2 mm of the implant coronal length will remain exposed. Implant will be stabilized in the fixture hole using a suitable room temperature curing epoxy.
• Angled abutment will be attached to the implant using the specified torque (or to a reasonable tightness).
• An axial compressive load of 500 N (112 LBF) will be applied to the abutment head at a crosshead speed of 0.05 inch per minute using a universal test machine. The load will be held for five (5) minutes and then released.
• Tested implant/abutment assemblies will be examined under an optical microscope for any damage and/or permanent deformation.

Fatigue Test - Five sets of implant/abutment assemblies will be prepared and tested as follows:

• Each implant/abutment assembly will be prepared as in static test described above.
• A cyclic axial compressive load between 20 N and 200 N (4.5 LBF and 45 LBF) will be applied to the abutment head for 5X106 cycles at a frequency of 15 Hz. Test will be conducted in air. A constant flow of normal lab air will be applied to test specimens during testing.
• Tested implant/abutment assemblies will be examined under an optical microscope for any damage and/or permanent deformation.

A final report will be submitted to Sargon Enterprises, Inc. which will include the test results and observations made during testing.

If test specimens experience premature failure during testing, a comprehensive failure analysis could be performed by ARTECH for an additional cost. This could generate recommendations which will be beneficial in making your system robust.

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September 21,1998

Ms. Mona Khachi
Sargon Enterprises, Inc.
260 South Beverly Drive
Second Floor
Beverly Hills, CA 90212

RE.: Mechanical Testing of 16 mm Implants
ARTECH Project No.: M80048
Sargon P.O. No.: 218

Dear Ms. Khachi:

Per your request, ARTECH has completed testing of 16 mm implant assemblies. Each implant assembly included a straight 16 mm implant and a 15° angled abutment. Test description and results are as follows:

Static Test -

• Five sets of implant assemblies were prepared and tested in the following manner:
  One implant was installed in each of the five vertical holes drilled in a test fixture. These holes were about 0.002 inch larger in diameter than the implant diameter. Its depth was such that 2 mm of the implant coronal length was exposed. Implants were stabilized in the fixture hole by using a room temperature curing epoxy.
• A supplied angled abutment was attached to each implant using the supplied screw. The screw was hand tightened using an allen wrench.
• An axial compressive load of 500 N (112 LBF) was applied to the abutment head of each implant assembly at a cross head speed of 0.05 inch per minute. See the test setup in Figure 1. The load was held for 5 minutes and then released.
• Tested implant assemblies were examined under an optical microscope at 30X. No damage to the implants or abutments was observed.

Fatigue Test -

One set of implant assembly was installed in each of the five individual test fixtures and prepared as described in the static test procedure. The test procedure and results are as follows:

A cyclic axial compressive load from 20 N to 200 N (4.5 LBF to 45 LBF) was applied to the abutment head of each implant assembly for 5X10`' cycles at a frequency of 15 Hz. Test was conducted in air. See the test setup in Figure 2. Number of cycles completed on five implants was 5020185, 5040569, 5070982, 5040842, and 5042173. Tested implant assemblies were examined under an optical microscope at 30X. No damage to the implants or abutment was observed.

Conclusion -

Based on the test results, it is concluded that the supplied implant assemblies meet Sargon's specified requirements of static and fatigue strengths.

If you have any questions or need further assistance, please contact me at (703)378 7263.

Sincerely,
ARTECH TESTING, LLC

V. Sahay
Managing Engineer
Materials & Testing Division

Figure 1: Photograph of the Test Setup for Static Test.

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Figure 2: Photograph of the Test Setup for Fatigue Test.

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