Compliance News
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Orthodontic Labs Have a High Interest and Tremendous Opportunities through Providing Orthodontic Aligners
What are the FDA Regulations on these devices? Today’s Orthodontic Labs have a high interest to incorporate orthodontic sequential aligners into their product offerings. The FDA has provided a very clear guidance for these devices through a product code (NXC) as a...
The FDA’s Requirements for Inhouse Processed Mouthguards
I have received a question from an ortho lab owner regarding some talk in the industry about a FDA requiring a 510(k) for the inhouse processing of a mouthguard. I have communicated with the FDA on this topic because there are mouthguards with 510(k) clearances. This...