Fed Regist. 2018 Mar 14;83(50):11144-5.
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).
美国食品药品监督管理局（FDA或该机构）正在发布一项命令，批准一份请愿书，该请愿书请求豁免非处方（OTC）假牙修复套件（产品代码EBO）的上市前通知要求。这些装置由诸如粉末和液体胶水的树脂单体系统等材料组成，旨在永久性地应用于假牙以修复裂缝或破损处。本命令豁免非处方假牙修复套件（II类器械）的上市前通知（510(k)）要求。对于非处方假牙修复套件，510(k)豁免立即生效。FDA正在根据《联邦食品、药品和化妆品法案》（FD&C法案）中允许豁免器械提交510(k)要求的条款发布本命令。
