KERR DISCOVERY DISPOSABLE FLUORIDE TRAY
FDA 510(k) clearance K780712 · decided 1978-05-17
Clearance details
- K-number
- K780712
- Device name
- KERR DISCOVERY DISPOSABLE FLUORIDE TRAY
- Applicant
- Kerr Corporation (Danbury)
- Decision
- Substantially Equivalent
- Date received
- 1978-04-26
- Decision date
- 1978-05-17
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- KMT
- Device class
- 1
- Regulation number
- 872.6870
- 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 |
|---|---|---|
| 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 |
| FLUORIDE GEL DISPOSABLE TRAY (K770064) | Lorvic Corp. | 1977-01-14 |
Recalls involving this device
No recalls on record reference this clearance.