Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart D — Prosthetic Devices](/submissions/DE/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 872.3560](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3560) → EBP — Reliner, Denture, Over The Counter

# EBP · Reliner, Denture, Over The Counter

_Dental · 21 CFR 872.3560 · Class 2_

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

## Overview

- **Product Code:** EBP
- **Device Name:** Reliner, Denture, Over The Counter
- **Regulation:** [21 CFR 872.3560](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3560)
- **Device Class:** 2
- **Review Panel:** [Dental](/submissions/DE)

## Identification

An OTC denture reliner is a device consisting of a material such as plastic resin that is intended to be applied as a permanent coating or lining on the base or tissue-contacting surface of a denture. The device is intended to replace a worn denture lining and may be available for purchase over the counter.

## Classification Rationale

Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. The special controls for this device are FDA's:

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 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 (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K121318](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBP/K121318.md) | PROSOFT | Perma Laboratories | Jun 6, 2012 | SESE |
| [K101771](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBP/K101771.md) | RELINE-IT MODEL RELINE-IT | Majestic Drug Co., Inc. | Sep 20, 2010 | SESE |
| [K790589](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EBP/K790589.md) | DENTURE-TIGHT | Den-Mat Corp. | Aug 10, 1979 | SESE |

## Top Applicants

- Perma Laboratories — 1 clearance
- Majestic Drug Co., Inc. — 1 clearance
- Den-Mat Corp. — 1 clearance

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

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