ZAFIRA®— 510(k) K254245
Substantially EquivalentNew Stetic, SA
FDA 510(k) clearance K254245 for ZAFIRA®, Substantially Equivalent on 2026-03-03. Applicant: New Stetic, SA. Device class: 2.
Clearance details
- Applicant
- New Stetic, SA
- Product code
- Code EBF
- Device class
- Class 2
- Regulation
- 21 CFR 872.3690
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Guarne, CO
Recent devices under product code EBF
view allMore clearances from New Stetic, SA
view allData sourced from openFDA. This site is unofficial and independent of the FDA.