510(k) K254109 ยท EMA Cement, Dental
G-CEM UNIVERSAL
| Applicant | GC America, Inc., Alsip IL, US |
| Decision | Substantially Equivalent, May 18, 2026 |
| Received | Dec 19, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254109
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.