510(k) K261728 ยท EJK Liner, Cavity, Calcium Hydroxide
One-Fil LC
| Applicant | Mediclus Co., Ltd., Cheongju-Si, KR |
| Decision | Substantially Equivalent, Jul 21, 2026 |
| Received | May 26, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261728
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.