FDA Grants 510(k) Exemption for Denture Repair Kits

The FDA issued an order exempting over-the-counter denture repair kits from 510(k) clearance requirements in response to a petition submitted by Hyman, Phelps & McNamara seeking a premarket notification exemption for the class II devices.

The agency determined that the product’s risks and characteristics were well established and that premarket notification was not necessary to provide reasonable assurance of the product’s safety and effectiveness, as long as it remains compliant with existing special controls.

The OTC products consist of materials like powder and liquid glues meant to be applied permanently to a denture to fix breaks or cracks. The agency believes that any changes in the device that could impact its safety or effectiveness will be readily detectable by routine analysis and nonclinical testing.