K183147 is an FDA 510(k) clearance for the BrackFix. This device is classified as a Adhesive, Bracket And Tooth Conditioner, Resin (Class II - Special Controls, product code DYH).
Submitted by Voco GmbH (Cuxhaven, DE). The FDA issued a Cleared decision on March 1, 2019, 108 days after receiving the submission on November 13, 2018.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3750.
| 510(k) Number | K183147 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 13, 2018 |
| Decision Date | March 01, 2019 |
| Days to Decision | 108 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | DYH — Adhesive, Bracket And Tooth Conditioner, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3750 |