DENTURE CLEANER
FDA 510(k) clearance K832387 · decided 1983-09-12
Clearance details
- K-number
- K832387
- Device name
- DENTURE CLEANER
- Applicant
- Tower Laboratories, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1983-07-19
- Decision date
- 1983-09-12
- Days to decision
- 55 days
- Clearance type
- Traditional
- Product code
- JER
- Device class
- 1
- Regulation number
- 872.3530
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| DENTA PLUS (K883403) | Connoisseurs Products Corp. | 1988-10-25 |
| ULTRASONIC DENTURE CLEANER (K881391) | Tatung Company of America, Inc. | 1988-08-26 |
| DENTURE CLEANSERS (K872521) | Dental Research Laboratories | 1987-08-11 |
| DURACLEAN DENTURE CLEANER (K852906) | Astron Dental Corp. | 1985-07-31 |
| ORAL SAFE (K840805) | Great Lakes Orthodontics, Ltd. | 1984-03-30 |
| ORAL SAFE (K832359) | Great Lakes Orthodontics, Ltd. | 1983-09-26 |
| DENTSPLY DENTURE CLEANER (K800166) | Dentsply Intl. | 1980-03-17 |
| PLAQUE-X DENTURE CLEANER (K792530) | Nexell Corp. | 1979-12-27 |
| DEN-MAT 4-MINUTE DENTURE CLEANER (K791925) | Den-Mat Corp. | 1979-10-26 |
| PLAQUE-X DENTURE CLEANSER (K791716) | Noxell | 1979-10-23 |
| SANI-DENT DENTURE CLEANER (K781779) | Sandi-Dent | 1978-11-08 |
| DENTURE CLEANSER & TOOTHPASTE IN ONE (K780254) | Richardson Merrel, Inc. | 1978-03-09 |
Recalls involving this device
No recalls on record reference this clearance.