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


2022-11-29

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.