K911271 is an FDA 510(k) clearance for the ADHESIVE PRECOATED BRACKETS. This device is classified as a Adhesive, Bracket And Tooth Conditioner, Resin (Class II - Special Controls, product code DYH).
Submitted by Unitek Corp. (Monrovia, US). The FDA issued a Cleared decision on May 29, 1991, 68 days after receiving the submission on March 22, 1991.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3750.
| 510(k) Number | K911271 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 22, 1991 |
| Decision Date | May 29, 1991 |
| Days to Decision | 68 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | DYH — Adhesive, Bracket And Tooth Conditioner, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3750 |