Medical Devices; Exemption From Premarket Notification; Class II Devices; Over-the-Counter Denture Repair Kit
Information
Type
Rule
Regulated products
Medical Devices
Published
March 14, 2018
Last updated
March 14, 2018
Description
Document number 2018-05116. The Food and Drug Administration (FDA or Agency) is publishing an order granting a petition requesting exemption from premarket notification requirements for over-the-counter (OTC) denture repair kits (Product Code EBO). These devices consist of material, such as a resin monomer system of powder and liquid glues, which is intended to be applied permanently to a denture to mend cracks or breaks. This order exempts OTC denture repair kits, class II devices, from premarket notification (510(k)). This exemption from 510(k) is immediately in effect for OTC denture repair kits. FDA is publishing this order in accordance with the section of the Federal Food, Drug, and Cosmetic Act (FD&C Act) permitting the exemption of a device from the requirement to submit a 510(k).
Tags
Organization
Country / Region
United States
License
Other (Public Domain)