KMT · Tray, Fluoride, Disposable
Dental · 21 CFR 872.6870 · Class 1
Overview
| Product Code | KMT |
|---|---|
| Device Name | Tray, Fluoride, Disposable |
| Regulation | 21 CFR 872.6870 |
| Device Class | Class 1 |
| Review Panel | Dental |
| GMP Exempt | Yes |
Identification
A disposable fluoride tray is a device made of styrofoam intended to apply fluoride topically to the teeth. To use the tray, the patient bites down on the tray which has been filled with a fluoride solution.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K031809 | PERIO PROTECT TRAY | Perio Protect, LLC | Jan 23, 2004 | SESE |
| K904914 | DENTAL VACUUM INJECTION TRAY | The Lebanon Vac-Tray Corp. | Dec 17, 1990 | SESE |
| K871784 | TOP FORM II TRAYS, DISPOS FOAM-LINED TOP GEL APPLI | Colgate-Hoyt Laboratories | May 27, 1987 | SESE |
| K853882 | SUPER SLICK | Tang Products | Nov 18, 1985 | SESE |
| K820104 | NUPRO* GEL TRAY | Johnson & Johnson Professionals, Inc. | Feb 23, 1982 | SESE |
| K811154 | HOYT ECONO-TRAY | Hoyt Laboratories | May 13, 1981 | SESE |
| K780712 | KERR DISCOVERY DISPOSABLE FLUORIDE TRAY | Kerr Corporation (Danbury) | May 17, 1978 | SESE |
| K770064 | FLUORIDE GEL DISPOSABLE TRAY | Lorvic Corp. | Jan 14, 1977 | SESE |
Top Applicants
- The Lebanon Vac-Tray Corp. — 1 clearance
- Tang Products — 1 clearance
- Perio Protect, LLC — 1 clearance
- Lorvic Corp. — 1 clearance
- Kerr Corporation (Danbury) — 1 clearance
