FDA Expands Laboratory Requirements

The FDA's product classifications are giving us light on manufacturing requirements. The following are examples of these product codes, their implementation, and how they may affect the dental laboratory's production.

The product classification for 3D printed denture teeth for the fabrication of preformed resin denture teeth for use in a denture base (Product Code PZY¹) is very straightforward. The product is a Class 2 device and is 510(k) exempt but it must be produced under the Quality System (QS) regulation. This is good news for dental laboratories 3D printing dentures. In layman's terms, the only requirements are that dental laboratories must use a 510(k)-cleared resin to print the denture teeth and operate under a Quality Management System.

This product classification includes surgical guides for dental implants and this modification will definitely have an impact on printed or milled surgical guides. The FDA added a note to the product classification to the Product Code NDP²stating that a dental laboratory or a surgical guide service provider must "register their establishment" and operate under a Quality Management System. This is the modification that occurred without "written guidance" for the industry to prepare for the change. In communications, the FDA Division of Industry and Consumer Education (DICE) specifically directed the author that the manufacturer of a CAD/CAM Class 1 dental implant surgical guide would be regulated as a device manufacturer and required to comply with the FDA requirements, including having to register their establishment, listing their product,³ and needing to follow the Quality System (QS) regulation.

The product classifications for dental implant abutments have direct modifications to the 510(k) requirements for the Ti blanks and Ti bases. Both of these implant abutments, Product Code NHA,⁴fall into the same FDA requirements for the 510(k) holders/manufacturers of implant abutments. These 510(k) varieties have a unique statement added to their instructions for use. Device manufacturers—whether a dental laboratory or a milling center—must be "validated milling centers." The FDA explains their requirements for these validated milling centers: "Like a contract manufacturer of any Class II medical device, a validated milling center is responsible for registration/listing of the facility and devices produced as well as implementation of manufacturing procedures in line with Quality System regulations."

The "establishment exemption" is being removed from more CAD/CAM procedures in dental laboratories. Those still using the traditional/analog/handmade methods will always have that exemption. But as an industry, the move to automated manufacturing will require more dental laboratories to register with the FDA and be open to the FDA audit.

The fear that so many dental laboratories have about the audit is misguided. The FDA does not want to shut down dental laboratories; it recognizes the critical role that these medical device manufacturers play in each patient's oral healthcare. Instead of fearing the FDA, owners should accept the fact that it is going to be involved in the laboratory industry and will not be going away. By becoming FDA compliant, a dental laboratory can bring many manufacturing procedures in-house, allowing them to stop outsourcing and gain higher profit margins on the medical devices provided directly to their dentist clients. Misinformation may have kept laboratories in the shadows, keeping them from building bigger and better businesses. Building a true CAD/CAM production business and touting FDA compliance can give laboratories an edge and help increase revenues.

Tim Torbenson is the President of EVO820.