K251196 is an FDA 510(k) clearance for the Composite Orthodontic Brackets and Buttons. This device is classified as a Bracket, Plastic, Orthodontic (Class II - Special Controls, product code DYW).
Submitted by Ec Certification Service GmbH (Sankt Veit An Der Glan, AT). The FDA issued a Cleared decision on April 21, 2025, 4 days after receiving the submission on April 17, 2025.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5470.
| 510(k) Number | K251196 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 17, 2025 |
| Decision Date | April 21, 2025 |
| Days to Decision | 4 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | DYW - Bracket, Plastic, Orthodontic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.5470 |