510(k) K254245 · EBF Material, Tooth Shade, Resin
ZAFIRA®
| Applicant | New Stetic, SA, Guarne, CO |
| Decision | Substantially Equivalent, Mar 3, 2026 |
| Received | Dec 29, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254245
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.