← Product Code [EBO](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBO) · K770091

# EMERGENCY FAST-FIX DENTURE REPAIR KIT (K770091)

_Mr. Clarence Hurst · EBO · Jan 24, 1977 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBO/K770091

## Device Facts

- **Applicant:** Mr. Clarence Hurst
- **Product Code:** [EBO](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBO.md)
- **Decision Date:** Jan 24, 1977
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.3570
- **Device Class:** Class 2
- **Review Panel:** Dental

## Regulatory Identification

An OTC denture repair kit is a device consisting of a material, such as a resin monomer system of powder and liquid glues, that is intended to be applied permanently to a denture to mend cracks or breaks. The device may be available for purchase over-the counter.

## Special Controls

*Classification.* Class II. The OTC denture repair kit is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to § 872.9. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” and
(2) “OTC Denture Reliners, Repair Kits, and Partially Fabricated Denture Kits.”

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBO/K770091](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBO/K770091)

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