TOP FORM II TRAYS, DISPOS FOAM-LINED TOP GEL APPLI
Device Facts
| Record ID | K871784 |
|---|---|
| Device Name | TOP FORM II TRAYS, DISPOS FOAM-LINED TOP GEL APPLI |
| Applicant | Colgate-Hoyt Laboratories |
| Product Code | KMT · Dental |
| Decision Date | May 27, 1987 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.6870 |
| Device Class | Class 1 |
Regulatory Classification
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.
