KMT
8 FDA 510(k) clearances · Product code
39 daysmedian time to decision
225 days90th percentile
8clearances measured
FDA profile
- Official device name
- Tray, Fluoride, Disposable
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.6870
- Medical specialty
- Dental
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 2002: 2
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 |
|---|---|---|
| PERIO PROTECT TRAY (K031809) | Perio Protect, LLC | 2004-01-23 |
| DENTAL VACUUM INJECTION TRAY (K904914) | The Lebanon Vac-Tray Corp. | 1990-12-17 |
| TOP FORM II TRAYS, DISPOS FOAM-LINED TOP GEL APPLI (K871784) | Colgate-Hoyt Laboratories | 1987-05-27 |
| SUPER SLICK (K853882) | Tang Products | 1985-11-18 |
| NUPRO* GEL TRAY (K820104) | Johnson & Johnson Professionals, Inc. | 1982-02-23 |
| HOYT ECONO-TRAY (K811154) | Hoyt Laboratories | 1981-05-13 |
| KERR DISCOVERY DISPOSABLE FLUORIDE TRAY (K780712) | Kerr Corporation (Danbury) | 1978-05-17 |
| FLUORIDE GEL DISPOSABLE TRAY (K770064) | Lorvic Corp. | 1977-01-14 |
Track KMT automatically
Every clearance here is in the API, with alerts when new ones post.