510(k) K254091 ยท EBD Coating, Filling Material, Resin
GLOSSY COAT (15ML)
| Applicant | YAMAHACHI DENTAL MFG., Co., Gamagori, JP |
| Decision | Substantially Equivalent, Apr 6, 2026 |
| Received | Dec 19, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254091
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.