K251196
- 510(k) number
- K251196
- Device name
- Composite Orthodontic Brackets and Buttons
- Applicant
- Ec Certification Service GmbH AT
- Product code
- DYW — Bracket, Plastic, Orthodontic
- Decision date
- 2025-04-21
- Date received
- 2025-04-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K251196.pdf
Official FDA record: K251196
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.