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# Exempt OTC Denture Repair Kits from 510(k) Requirements: Petition
- URL: https://www.fdaweb.com/exempt-otc-denture-repair-kits-from-510-k-requirements-petition/
- Published: 2017-08-23T12:00:00.000Z
- Updated: 2026-09-14T22:43:08.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5139451

Hyman, Phelps & McNamara is asking FDA to add over-the-counter denture repair kits to the list of Class 2 medical devices with reasonable assurances of safety and effectiveness that can be exempted from 510(k) premarket notification requirements. A [petition](https://www.regulations.gov/document?D=FDA-2017-P-5124-0001&ref=fdaweb.com) tells the agency that the kits are “low-risk devices with a 40-year record of safety and effectiveness” and are “nearly identical in risk and purpose to other dental devices included on FDA’s exempt list.”

The law firm says it represents many medical device manufacturers who would greatly benefit from the ability to introduce low-risk, safe, and effective products into the marketplace without the need to first obtain premarket clearance. In 3/14 comments on the agency’s notice of a list of Class 2 devices that it proposed to exempt from the requirements, the firm requested that OTC denture repair kits be included. It says that the kits were not on FDA’s 7/11 final list and the agency never addressed the firm’s comment.

FDA has historically treated several oral care devices in a similar manner, the petition says. It notes that “there is no publicly available information indicating that the risk of OTC denture repair kits has changed … resulting in them having a different safety and effectiveness profile as compared to other now 510(k)-exempt denture products. FDA should, accordingly, continue to treat OTC denture repair kits the same as OTC denture cushions, OTC denture pads, OTC denture reliners, and partially fabricated denture kits, all of which FDA has determined as having similar risks and controls, and it should exempt OTC denture repair kits from the premarket notification requirements.”