Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart D — Prosthetic Devices](/submissions/DE/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 872.3530](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3530) → JER — Cleaner, Denture, Mechanical

# JER · Cleaner, Denture, Mechanical

_Dental · 21 CFR 872.3530 · Class 1_

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

## Overview

- **Product Code:** JER
- **Device Name:** Cleaner, Denture, Mechanical
- **Regulation:** [21 CFR 872.3530](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3530)
- **Device Class:** 1
- **Review Panel:** [Dental](/submissions/DE)

## Identification

A mechanical denture cleaner is a device, usually AC-powered, that consists of a container for mechanically agitating a denture cleansing solution. The device is intended to clean a denture by submersion in the agitating cleansing solution in the container.

## Classification Rationale

Class I (general 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.

## Recent Cleared Devices (14 of 14)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K883403](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/JER/K883403.md) | DENTA PLUS | Connoisseurs Products Corp. | Oct 25, 1988 | SESE |
| [K881391](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/JER/K881391.md) | ULTRASONIC DENTURE CLEANER | Tatung Company of America, Inc. | Aug 26, 1988 | SESE |
| [K872521](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/JER/K872521.md) | DENTURE CLEANSERS | Dental Research Laboratories | Aug 11, 1987 | SESE |
| [K852906](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/JER/K852906.md) | DURACLEAN DENTURE CLEANER | Astron Dental Corp. | Jul 31, 1985 | SESE |
| [K840805](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/JER/K840805.md) | ORAL SAFE | Great Lakes Orthodontics, Ltd. | Mar 30, 1984 | SESE |
| [K832359](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/JER/K832359.md) | ORAL SAFE | Great Lakes Orthodontics, Ltd. | Sep 26, 1983 | SESE |
| [K832387](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/JER/K832387.md) | DENTURE CLEANER | Tower Laboratories, Ltd. | Sep 12, 1983 | SESE |
| [K800166](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/JER/K800166.md) | DENTSPLY DENTURE CLEANER | Dentsply Intl. | Mar 17, 1980 | SESE |
| [K792530](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/JER/K792530.md) | PLAQUE-X DENTURE CLEANER | Nexell Corp. | Dec 27, 1979 | SESE |
| [K791925](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/JER/K791925.md) | DEN-MAT 4-MINUTE DENTURE CLEANER | Den-Mat Corp. | Oct 26, 1979 | SESE |
| [K791716](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/JER/K791716.md) | PLAQUE-X DENTURE CLEANSER | Noxell | Oct 23, 1979 | SESE |
| [K781779](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/JER/K781779.md) | SANI-DENT DENTURE CLEANER | Sandi-Dent | Nov 8, 1978 | SESE |
| [K780254](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/JER/K780254.md) | DENTURE CLEANSER & TOOTHPASTE IN ONE | Richardson Merrel, Inc. | Mar 9, 1978 | SESE |
| [K780174](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/JER/K780174.md) | ORABRITE | Norcliff Thayer, Inc. | Feb 23, 1978 | SESE |

## Top Applicants

- Great Lakes Orthodontics, Ltd. — 2 clearances
- Astron Dental Corp. — 1 clearance
- Connoisseurs Products Corp. — 1 clearance
- Den-Mat Corp. — 1 clearance
- Dental Research Laboratories — 1 clearance

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

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