510(k) K254063 ยท EMA Cement, Dental
iCEM Universal Plus
| Applicant | Kulzer, LLC, South Bend IN, US |
| Decision | Substantially Equivalent, Dec 19, 2025 |
| Received | Dec 17, 2025 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K254063
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.