Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart D — Prosthetic Devices](/submissions/DE/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 872.3570](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3570) → EBO — Denture Repair Kit

# EBO · Denture Repair Kit

_Dental · 21 CFR 872.3570 · Class 2_

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

## Overview

- **Product Code:** EBO
- **Device Name:** Denture Repair Kit
- **Regulation:** [21 CFR 872.3570](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3570)
- **Device Class:** 2
- **Review Panel:** [Dental](/submissions/DE)

## 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.

## Classification Rationale

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:

## 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.”

## Recent Cleared Devices (7 of 7)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K850927](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBO/K850927.md) | COMPLETE DENTURE REPAIR KIT | Tooth Aid Lab, Inc. | Jul 2, 1985 | SESE |
| [K844480](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBO/K844480.md) | DENTAL ORAL CARE SYSTEMS & COMPONENTS | Advanced Bio Systems, Inc. | Jun 19, 1985 | SN |
| [K833057](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBO/K833057.md) | UNIVERSAL FIX-A-PLATE | Laurentian Laboratories | Feb 27, 1984 | SESE |
| [K833056](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBO/K833056.md) | UNIVERSAL LINE-A-PLATE | Laurentian Laboratories | Feb 27, 1984 | SESE |
| [K820685](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBO/K820685.md) | DENTURE ADJUSTMENT KIT | Camdent Laboratories | Apr 9, 1982 | SESE |
| [K820245](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBO/K820245.md) | SAFE TDENT | Professional Dental Studios | Apr 9, 1982 | SESE |
| [K770091](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBO/K770091.md) | EMERGENCY FAST-FIX DENTURE REPAIR KIT | Mr. Clarence Hurst | Jan 24, 1977 | SESE |

## Top Applicants

- Laurentian Laboratories — 2 clearances
- Tooth Aid Lab, Inc. — 1 clearance
- Professional Dental Studios — 1 clearance
- Mr. Clarence Hurst — 1 clearance
- Camdent Laboratories — 1 clearance

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

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