FLUORIDE GEL DISPOSABLE TRAY
FDA 510(k) clearance K770064 · decided 1977-01-14
Clearance details
- K-number
- K770064
- Device name
- FLUORIDE GEL DISPOSABLE TRAY
- Applicant
- Lorvic Corp.
- Decision
- Substantially Equivalent
- Date received
- 1977-01-11
- Decision date
- 1977-01-14
- Days to decision
- 3 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
+ Add to Predicate Builder ◉ Watch Lorvic Corp.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| KERR DISCOVERY DISPOSABLE FLUORIDE TRAY (K780712) | Kerr Corporation (Danbury) | 1978-05-17 |
Recalls involving this device
No recalls on record reference this clearance.