UNITEK PALATAL BAR
Device Facts
| Record ID | K812239 |
|---|---|
| Device Name | UNITEK PALATAL BAR |
| Applicant | Unitek Corp. |
| Product Code | DYT · Dental |
| Decision Date | Sep 21, 1981 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.5525 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A preformed tooth positioner is a plastic device that is an impression of a perfected bite intended to prevent a patient's teeth from shifting position or to move teeth to a final position after orthodontic appliances (braces) have been removed. The patient bites down on the device for several hours a day to force the teeth into a final position or to maintain the teeth in their corrected position.
