# Medical Devices; Exemption From Premarket Notification; Class II Devices; Over-the-Counter Denture Repair Kit
> **Food and Drug Administration** · Final order. · Published 2018-03-14 · Effective 2018-03-14 · 83 FR 11144
## Document
- **Document number:** 2018-05116
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 83 FR 11144
- **CFR reference:** 21 CFR 872
- **Publication date:** 2018-03-14
- **Effective date:** 2018-03-14
- **HHS docket:** Docket No. FDA-2017-P-5124
## Abstract

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).

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2018/03/14/2018-05116/medical-devices-exemption-from-premarket-notification-class-ii-devices-over-the-counter-denture)
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