510(k) K070190 ยท EBF Material, Tooth Shade, Resin
GRADIA DIRECT X
| Applicant | GC America, Inc., Alsip IL, US |
| Decision | Substantially Equivalent, Mar 12, 2007 |
| Received | Jan 22, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070190
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.