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.

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