510(k) K011517 ยท EBF Material, Tooth Shade, Resin
LUTE; CORE
| Applicant | First Scientific Limited, Blaenau Gwent, Wales, GB |
| Decision | Substantially Equivalent, Jul 10, 2001 |
| Received | May 17, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011517
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.