FDA Approved Products and FDA Requirements for Labs
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.