JER
14 FDA 510(k) clearances · Product code
52 daysmedian time to decision
144 days90th percentile
14clearances measured
FDA profile
- Official device name
- Cleaner, Denture, Mechanical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.3530
- Medical specialty
- Dental
- Adverse events (MAUDE)
- 2001: 1 · 2004: 8 · 2005: 6 · 2006: 3
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| 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 |
| DENTURE CLEANER (K832387) | Tower Laboratories, Ltd. | 1983-09-12 |
| 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 |
| ORABRITE (K780174) | Norcliff Thayer, Inc. | 1978-02-23 |
Track JER automatically
Every clearance here is in the API, with alerts when new ones post.