The following data is part of a premarket notification filed by Unitek Corp. with the FDA for Unitek Palatal Bar.
| Device ID | K812239 |
| 510k Number | K812239 |
| Device Name: | UNITEK PALATAL BAR |
| Classification | Maintainer, Space Preformed, Orthodontic |
| Applicant | UNITEK CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DYT |
| CFR Regulation Number | 872.5525 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-08-11 |
| Decision Date | 1981-09-21 |