FDA Says No To CAD/CAM In-Lab Milling

FDA Says No To CAD/CAM In-Lab Milling

Posted by on Nov 22, 2015 in Regulatory News | No Comments

When FDA began studying the use of CAD/CAM in dental laboratory technology, the FDA’s initial focus was on angulation and the implant/abutment interface. FDA ultimately made clear statements that anyone making the implant/abutment interface is a “manufacturer” as such must obtain 510(k) clearance to do so…