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 |
|---|---|---|---|
| D974BSIDLB1 | Britedent | Bright Supply, Inc. | 2024-03-12 |
| D974BSIDLW1 | Britedent | Bright Supply, Inc. | 2024-03-12 |
| D974BSIRHB1 | Britedent | Bright Supply, Inc. | 2024-03-12 |
| D974BSIRHW1 | Britedent | Bright Supply, Inc. | 2024-03-12 |
| D974BSIRHW2 | Britedent | Bright Supply, Inc. | 2024-03-12 |
| D974BSIRHB2 | Britedent | Bright Supply, Inc. | 2024-03-12 |
| D974BSIDLW0 | Britedent | Bright Supply, Inc. | 2024-03-12 |
| D974BSIDLB2 | Britedent | Bright Supply, Inc. | 2024-03-12 |
| D974BSIDASST1 | Britedent | Bright Supply, Inc. | 2024-03-11 |
| D974BSIRASST2 | Britedent | Bright Supply, Inc. | 2024-03-11 |
| D974BSIDASST2 | Britedent | Bright Supply, Inc. | 2024-03-11 |
| D974BSIRASST1 | Britedent | Bright Supply, Inc. | 2024-03-11 |
| J009670010000 | Sympro | Renfert GmbH | 2023-07-10 |
| D746RBUSC1 | Cordless Sonic Cleaner | DENTSPLY SIRONA ORTHODONTICS INC. | 2023-06-13 |
| D746RBUSCC1 | Cordless Sonic Cleaner | DENTSPLY SIRONA ORTHODONTICS INC. | 2023-06-13 |
| D687215051 | Cleanlets | Sultan Healthcare Inc | 2022-11-30 |
| 00814832011093 | EFFDNT DENT BATH KIT 1CT | Medtech Products Inc. | 2022-09-30 |
| 00348783003840 | Pro Clean | PREMIER DENTAL PRODUCTS COMPANY | 2022-06-29 |
| 00348783003833 | Pro Clean | PREMIER DENTAL PRODUCTS COMPANY | 2022-06-29 |
| 00348783003826 | Pro Clean | PREMIER DENTAL PRODUCTS COMPANY | 2022-06-29 |
| D6919011102 | Pro Clean | PREMIER DENTAL PRODUCTS COMPANY | 2022-06-29 |
| D6919011103 | Pro Clean | PREMIER DENTAL PRODUCTS COMPANY | 2022-06-29 |
| D6919011992 | Pro Clean | PREMIER DENTAL PRODUCTS COMPANY | 2022-06-29 |
| D746RB368C1 | RETAINER BRITE® | DENTSPLY SIRONA ORTHODONTICS INC. | 2021-05-01 |
| H65890040891 | Henry Schein | HENRY SCHEIN, INC. | 2019-05-15 |