Product code JER
- Device name
- Cleaner, Denture, Mechanical
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.3530
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K883403 | DENTA PLUS | Connoisseurs Products Corp. | 1988-10-25 |
| K881391 | ULTRASONIC DENTURE CLEANER | Tatung Company of America, Inc. | 1988-08-26 |
| K872521 | DENTURE CLEANSERS | Dental Research Laboratories | 1987-08-11 |
| K852906 | DURACLEAN DENTURE CLEANER | Astron Dental Corp. | 1985-07-31 |
| K840805 | ORAL SAFE | Great Lakes Orthodontics, Ltd. | 1984-03-30 |
| K832359 | ORAL SAFE | Great Lakes Orthodontics, Ltd. | 1983-09-26 |
| K832387 | DENTURE CLEANER | Tower Laboratories, Ltd. | 1983-09-12 |
| K800166 | DENTSPLY DENTURE CLEANER | Dentsply Intl. | 1980-03-17 |
| K792530 | PLAQUE-X DENTURE CLEANER | Nexell Corp. | 1979-12-27 |
| K791925 | DEN-MAT 4-MINUTE DENTURE CLEANER | Den-Mat Corp. | 1979-10-26 |
| K791716 | PLAQUE-X DENTURE CLEANSER | Noxell | 1979-10-23 |
| K781779 | SANI-DENT DENTURE CLEANER | Sandi-Dent | 1978-11-08 |
| K780254 | DENTURE CLEANSER & TOOTHPASTE IN ONE | Richardson Merrel, Inc. | 1978-03-09 |
| K780174 | ORABRITE | Norcliff Thayer, Inc. | 1978-02-23 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00840456223840 | JMU | JMU DENTAL, INC | 2026-08-18 |
| 00840456223987 | JMU | JMU DENTAL, INC | 2026-08-18 |
| 00840456223970 | JMU | JMU DENTAL, INC | 2026-08-18 |
| 00840456223963 | JMU | JMU DENTAL, INC | 2026-08-18 |
| 00840456223956 | JMU | JMU DENTAL, INC | 2026-08-18 |
| 00840456223949 | JMU | JMU DENTAL, INC | 2026-08-18 |
| 00840456223932 | JMU | JMU DENTAL, INC | 2026-08-18 |
| 00840456223925 | JMU | JMU DENTAL, INC | 2026-08-18 |
| 00840456223918 | JMU | JMU DENTAL, INC | 2026-08-18 |
| 00840456223901 | JMU | JMU DENTAL, INC | 2026-08-18 |
| 00840456223895 | JMU | JMU DENTAL, INC | 2026-08-18 |
| 00840456223888 | JMU | JMU DENTAL, INC | 2026-08-18 |
| 00840456223871 | JMU | JMU DENTAL, INC | 2026-08-18 |
| 00840456223864 | JMU | JMU DENTAL, INC | 2026-08-18 |
| 00840456223857 | JMU | JMU DENTAL, INC | 2026-08-18 |
| 00840456201336 | JMU | JMU DENTAL, INC | 2026-08-18 |
| 00840456223833 | JMU | JMU DENTAL, INC | 2026-08-18 |
| 00840456223826 | JMU | JMU DENTAL, INC | 2026-08-18 |
| 00840456223819 | JMU | JMU DENTAL, INC | 2026-08-18 |
| 00840456216491 | JMU | JMU DENTAL, INC | 2026-08-18 |
| 00840456216484 | JMU | JMU DENTAL, INC | 2026-08-18 |
| 00840456216477 | JMU | JMU DENTAL, INC | 2026-08-18 |
| 00840456201411 | JMU | JMU DENTAL, INC | 2026-08-18 |
| 00840456201404 | JMU | JMU DENTAL, INC | 2026-08-18 |
| 00840456201398 | JMU | JMU DENTAL, INC | 2026-08-18 |
| 00840456201381 | JMU | JMU DENTAL, INC | 2026-08-18 |
| 00840456201374 | JMU | JMU DENTAL, INC | 2026-08-18 |
| 00840456201367 | JMU | JMU DENTAL, INC | 2026-08-18 |
| 00840456201350 | JMU | JMU DENTAL, INC | 2026-08-18 |
| 00840456201343 | JMU | JMU DENTAL, INC | 2026-08-18 |