510(k) K251946 ยท EBF Material, Tooth Shade, Resin
G aenial Universal Injectable II
| Applicant | GC America, Inc., Alsip IL, US |
| Decision | Substantially Equivalent, Aug 29, 2025 |
| Received | Jun 25, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251946
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.