510(k) K972594 ยท KLE Agent, Tooth Bonding, Resin
METALPRIMER II
| Applicant | GC America, Inc., Alsip IL, US |
| Decision | Substantially Equivalent, Aug 26, 1997 |
| Received | Jul 11, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972594
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.