What Contents Should Be Included At Least In The Device Characteristic Description On The Product Structure And Design Of Dental Implant?

The device characteristic description on the product structure and design of dental implant should at least include the following:

1. Implant shape, specific nominal values and tolerances of length and diameter (e.g. body diameter and platform diameter);
2. Macroscopic design parameters of threads (e.g. single­thread, double-thread, triple-thread). Geometric parameters of thread unit, include thread shapes (e.g. V-shaped, rectangle, saw tooth, buttress thread, reverse-buttress thread, and square), thread pitch and thread depth;
3. Implant neck characteristics (e.g. bone level, soft tissue level);
4. Contour design of implant apex region (e.g. blunt, sharp, cylindrical, conical) and apex region thread angle (e.g. symmetrical, upper flat and lower taper, upper taper and lower flat);
5. Implant-abutment connection type (e.g. internal hexagon connection, external octagon connection and Morse taper connection);
6. Axial plane characteristics of the implant (e.g. axial anti­rotation groove);
7. Platform switching design (if any);
8. Other structure and design characteristics specific to the product under application.