510(k) K240304 ยท KIF Resin, Root Canal Filling
Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5)
| Applicant | Enpuno Biotechnology Co., Ltd., Changsha High-Tech Development Zone Chan, CN |
| Decision | Substantially Equivalent, May 28, 2024 |
| Received | Feb 2, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K240304
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.