510(k) K262478 ยท KIF Resin, Root Canal Filling
BCS Bioceramic Sealer
| Applicant | BCS Device Pte., Ltd., Singapore, SG |
| Decision | Substantially Equivalent, Oct 16, 2026 |
| Received | Jul 20, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K262478
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.