FDA "Discovers" Dental Laboratories

Historically, the FDA—long involved in overseeing the manufacturers of dental laboratory materials—paid minimal attention to dental laboratories. In 2004, due to the dramatic rise in imports from overseas laboratories, that changed. Concerned that these restorations might not contain FDA-approved materials, the FDA started taking a closer look at foreign laboratories and consequently, the domestic operations that imported cases from them. Several laboratories reported random inspections and, later that year, the FDA invited the NADL to a meeting to discuss its concerns about public safety.

In 2015, our industry’s proliferation of milling in-house custom abutments­­—a Class II medical device—caught the FDA’s attention again. This resulted in an NADL alert about increased enforcement of a 2004 FDA guidance document that states—among other things—only 510(k) holders can CAD/CAM mill an abutment blank in house.

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