NADL Issues FDA Alert Regarding In-Lab Milling of Abutments

The industry is abuzz with questions and concerns about the FDA’s newest statement on in-lab milling of implant abutments (see NADL alert below). Watch for additional coverage in LMT.

From NADL:
FDA Alert - Labs not permitted to use CAD/CAM for in-lab milling of most abutments

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.

That still did not answer the questions about the “tooth end” of the abutment, the abutment collar/post. Sometime later FDA ultimately stated a dental laboratory may mill the collar/post as long as the dental laboratory follows the manufacturer's FDA cleared instructions.

Now, nearly...