Performed Tests

The following tests were performed as a part of FDA approval process:

Implant Fatigue Test

This test was conducted per FDA Class II Special Control Guidance Document: Root-Form Dental Implants and Endosseous Dental Abutments, issued on May 12, 2004.

Results:

A 3.5mm implant is able to withstand 5 million cycles of 425N load application. Conventional two piece implants of the same size can rarely withstand more than 200N of load (a typical example, NobelActive™1 3.5, can survive only 222N of load under the conditions of this test). Larger size implants may also be not as strong. Nobel Biocare reports 355N for NobelActive 4.3.

Key/Abutment Weld Strength Test

This test was designed to prove the safety of abutment/key connection and to validate abutment preparation guidelines.

Results:

The abutment to key connection was able to withstand at least 36.7Ncm of torque during multiple cycles (up to 25 cycles were administered). The torque measurements were taken after maximum abutment preparation was done.

The following information was taken into consideration to design the test:

1. The torque, needed to disengage a fully engaged abutment (seated at 15Ncm), is 11Ncm.
2. The number of engagement/disengagement cycles used during prosthesis fabrication is typically two, but can be as high as five if lab adjustments are needed.

Conclusion:

The three point weld between KAT abutment and the key has sufficient strength if preparation requirements are not violated.

Implant Insertion Torque Test

This test was designed to establish the safe amount of insertion torque for KAT implants.

Results:

Implants were able to resist multiple (up to twenty) applications of torque ranging from 101.8 to 127.6Ncm without deformation.

Conclusion:

KAT implants can withstand torque in the range of 100 to 120Ncm without deformation of abutment receiving post. Torque applications of up to 70Ncm, commonly associated with implant placement into the bone, will not cause deformation of KAT implants.

KAT Implant Locking Taper Connection Accuracy Test

This test was designed to establish the accuracy of press fit locking taper connection in a vertical plane.

Results:

KAT Implants System can achieve locking taper engagement accuracy to within 10 microns in a vertical plane.

Conclusion:

Locking taper connection between KAT implant and KAT abutment is highly accurate and predictable, as long as the same abutment is used in all phases, including implant indexing, of prosthesis fabrication (Pick-Up Abutment™ impression method).

¹ NobelActive is a trademark of Nobel Biocare.