K812239 is an FDA 510(k) clearance for the UNITEK PALATAL BAR. This device is classified as a Maintainer, Space Preformed, Orthodontic (Class I - General Controls, product code DYT).
Submitted by Unitek Corp. (Walker, US). The FDA issued a Cleared decision on September 21, 1981, 41 days after receiving the submission on August 11, 1981.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5525.
| 510(k) Number | K812239 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 11, 1981 |
| Decision Date | September 21, 1981 |
| Days to Decision | 41 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | DYT — Maintainer, Space Preformed, Orthodontic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.5525 |