There is a lot of confusion with trying to understand what the FDA’s involvement is with regards to implant abutments and CAD/CAM restorations.  You’ve probably heard of the “legal” vs “illegal” discussion, but don’t understand the back story or why laboratories are no longer FDA exempt and now need to incorporate a Quality Management System to deliver cleared medical devices.  We are dental industry professionals that understand the regulatory guidance from the FDA and we are here to help you.

Contact us for more information.