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    Increasing FDA involvement in CAD/CAM dental restorations

    Outsourcing manufacturing has led to increased regulatory oversight, but most labs might already be FDA compliant.

    How does FDA oversight affect the lab and what does it mean to the clinician? Our web feature this month seeks to clarify the issue and present best practices for clinicians and labs to comply with FDA regulations. 

    Computer Aided Design and Computer Aided Manufacturing (CAD/CAM) have revolutionized dentistry. Not only has the technology improved the way restorations are designed and created, but it has also increased the speed of delivery the patient. CAD/CAM technology has also made some restorations possible that at one time might have seemed impossible. 

    Conversely, CAD/CAM dentistry has also created concerns in the FDA about the need for oversight and regulation. Some dental laboratories began receiving FDA compliance letters a couple of years ago, regarding product descriptions on their websites. Many dental professionals and dental technicians wondered what the FDA’s involvement meant for the future of dental labs that use CAD/CAM technology.

    What are the FDA regulations for CAD/CAM manufacturing of dental restorations?

    It started with the implant abutment. Dental laboratories adjusted implant/abutment interfaces by hand for years without FDA oversigh, and many still do.

    Evo820 is a consulting firm that helps dental laboratories who use CAD/CAM technology comply with FDA regulations. Tim Torbenson, President of evo820, says that dental laboratories have been enjoying an exemption from FDA registration and listing requirements under Code of Federal Regulations Title 21. 21 CFR 807.65(i).

    As Torbenson explains, the modifications of implant abutments were exempt because everything was done by hand and every lab has their own way of doing things. 

    “It was a craft and less like device manufacturing, where each device was handmade specifically to accommodate a patient. There was no way for the FDA to regulate that because everyone did it differently,” Torbenson says.

    Steve Tapie is the implant manager for Keating Dental Arts Dental Laboratories with 35 years’ experience working in dental labs. He says they modify stock titanium abutments because the companies they work with are already cleared by the FDA, but not with a machine.

    “We can alter them a little bit,” Tapie says. “We don’t have a mill we put them in, they are hand-altered.”

    However, as more labs milled custom implant abutments with CAD/CAM technology, the FDA began to take a closer look. The FDA wanted to ensure that labs are using mills and materials validated for use with the software and in-lab milling.  

    CAD/CAM restorationsTorbenson says that the FDA did not change its stance concerning dental laboratories and the restorations that they manufacture, but that some dental laboratories have moved into a position that now may require more FDA compliance when they advanced and incorporated some of the new technologies.

    “The FDA has always been very clear that the abutment that goes into the implant — the implant abutment interface — has always been subject to a 510(k),” Eric Thorn, in-house counsel for the National Association of Dental Laboratories (NADL) says. 

    According to Thorn,  labs began incorporating more CAD/CAM into their implant making back in the early 2010s, which triggered inquiries from the FDA. 

    Continue to page 2 to read more... 

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