510(k) K042348 ยท EBF Material, Tooth Shade, Resin
GRADIA DIRECT LOFLO
| Applicant | GC America, Inc., Alsip IL, US |
| Decision | Substantially Equivalent, Nov 18, 2004 |
| Received | Aug 30, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042348
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.