K254245
- 510(k) number
- K254245
- Device name
- ZAFIRA®
- Applicant
- New Stetic, SA CO
- Product code
- EBF — Material, Tooth Shade, Resin
- Decision date
- 2026-03-03
- Date received
- 2025-12-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K254245.pdf
Official FDA record: K254245
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.