DENTAL VACUUM INJECTION TRAY
Device Facts
| Record ID | K904914 |
|---|---|
| Device Name | DENTAL VACUUM INJECTION TRAY |
| Applicant | The Lebanon Vac-Tray Corp. |
| Product Code | KMT · Dental |
| Decision Date | Dec 17, 1990 |
| 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.