Submission Details
| 510(k) Number | K251196 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
Composite Orthodontic Brackets and Buttons
Apr 2025
Decision
4d
Days
Class 2
Risk
About This 510(k) Submission
K251196 is an FDA 510(k) clearance for the Composite Orthodontic Brackets and Buttons, 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 review panel. Regulated under 21 CFR 872.5470.
Device Classification
| Product Code | DYW — Bracket, Plastic, Orthodontic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 872.5470 |
Manufacturer
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