The FDA is now monitoring dental labs. Their requirements are simple; use FDA approved Ti Bases and FDA approved Premills.
To help you understand we have provided below further information on the subject.
DESS Ti Bases and ANGLEBases are FDA approved. Please review the DESS 510(k) documentation.
What this means is that the smallest platform of the specific implant system are tested with a 5mm wide by 11mm tall zirconia placed at a 30° angle and applied over 300ncm to 350ncm of force for 5 million times!
Without the zirconia breaking or debonding, screw breaking or bending, or ti base breaking or bending. This testing is for both the engaging and non engaging connections and is a REQUIREMENT for ALL implant systems. There are NO substitutes.
Our FDA Approved Ti Bases document briefly describes the testing that is required by the FDA for every ti base platform.
The EVO FDA Requirements article from EVO 820 goes into detail about the requirements for labs. We recommend reading section "3. Abutment, Implant, Dental, Endosseous" which highlights the requirement that all ti bases and premills have a 510(k).
We cannot stress enough the importance that you ensure the parts you are purchasing from your vendor are 510(k); especially for the implant system, platform, and component type. There are NO substitutions.
The video below by EVO 820 explains how the FDA defines the use of an implant component by dental labs. We recommend viewing the video between timeframe 14:25 to 20:31 specifically.