FDA Approved Products and FDA Requirements for Labs

The FDA is now monitoring dental labs. Their requirements are simple; use FDA approved Ti Bases, FDA approved Pre-mills, and FDA approved components.

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 have been tested as 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 Pre-mills 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.