JER · Cleaner, Denture, Mechanical
Dental · 21 CFR 872.3530 · Class 1
Overview
| Product Code | JER |
|---|---|
| Device Name | Cleaner, Denture, Mechanical |
| Regulation | 21 CFR 872.3530 |
| Device Class | Class 1 |
| Review Panel | Dental |
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 | DENTA PLUS | Connoisseurs Products Corp. | Oct 25, 1988 | SESE |
| K881391 | ULTRASONIC DENTURE CLEANER | Tatung Company of America, Inc. | Aug 26, 1988 | SESE |
| K872521 | DENTURE CLEANSERS | Dental Research Laboratories | Aug 11, 1987 | SESE |
| K852906 | DURACLEAN DENTURE CLEANER | Astron Dental Corp. | Jul 31, 1985 | SESE |
| K840805 | ORAL SAFE | Great Lakes Orthodontics, Ltd. | Mar 30, 1984 | SESE |
| K832359 | ORAL SAFE | Great Lakes Orthodontics, Ltd. | Sep 26, 1983 | SESE |
| K832387 | DENTURE CLEANER | Tower Laboratories, Ltd. | Sep 12, 1983 | SESE |
| K800166 | DENTSPLY DENTURE CLEANER | Dentsply Intl. | Mar 17, 1980 | SESE |
| K792530 | PLAQUE-X DENTURE CLEANER | Nexell Corp. | Dec 27, 1979 | SESE |
| K791925 | DEN-MAT 4-MINUTE DENTURE CLEANER | Den-Mat Corp. | Oct 26, 1979 | SESE |
| K791716 | PLAQUE-X DENTURE CLEANSER | Noxell | Oct 23, 1979 | SESE |
| K781779 | SANI-DENT DENTURE CLEANER | Sandi-Dent | Nov 8, 1978 | SESE |
| K780254 | DENTURE CLEANSER & TOOTHPASTE IN ONE | Richardson Merrel, Inc. | Mar 9, 1978 | SESE |
| K780174 | ORABRITE | Norcliff Thayer, Inc. | Feb 23, 1978 | SESE |
Top Applicants
- Great Lakes Orthodontics, Ltd. — 2 clearances
- Tower Laboratories, Ltd. — 1 clearance
- Tatung Company of America, Inc. — 1 clearance
- Sandi-Dent — 1 clearance
- Richardson Merrel, Inc. — 1 clearance
