510(k) K951297 ยท EJT Alloy, Gold-Based Noble Metal
HARMONY LINE KF
| Applicant | Ivoclar North America, Inc., Amherst NY, US |
| Decision | Substantially Equivalent, Apr 18, 1995 |
| Received | Mar 22, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K951297
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.