510(k) K010475 ยท EBF Material, Tooth Shade, Resin
D/C CORE MATERIAL
| Applicant | Parkell, Inc., Farmingdale NY, US |
| Decision | Substantially Equivalent, May 7, 2001 |
| Received | Feb 20, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010475
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.