510(k) K971513 ยท EBF Material, Tooth Shade, Resin
COMPOGLASS F
| Applicant | Ivoclar North America, Inc., Amherst NY, US |
| Decision | Substantially Equivalent, Jun 3, 1997 |
| Received | Apr 28, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971513
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.