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 can create some confusion for those who want to remain FDA compliant or legal.

I had communication with an FDA regarding this topic some time ago. I presented Micheal Adjodha, Assistant Director at the Division of Dental Devices a scenario where the ortho lab receives a prescription for a mouthguard is prescribed by the dentist, as a means of treating bruxism (excessive teeth grinding or jaw clenching) by covering the top half of the teeth with a polymer guard. My question is, does this laboratory need to have a 510(k) to process the mouthguard?

Micheal Adjodha of the FDA responded:

“In the process you describe below, it appears that the lab is not developing specifications for the device but is patient-matching a device per a dentist’s prescription. This appears to fall under the exemption provided in 21 CFR 807.65(i). Consequently, registration, listing and 510(k) is not required for this activity by the dental laboratory. I am assuming, of course, that the material to fabricate the mouthguard has already received 510(k)clearance for its intended use.”

With this information directly from the Assistant Director of the Division of Dental Devices, I can comfortably inform you that there is no 510(k) requirements for inhouse manufacturing and processing of mouthguards.

If you ever have any questions, please post them to this website and I will respond quickly.

Regards,
Tim Torbenson
President