510(k) K974089 ยท KLE Agent, Tooth Bonding, Resin
ALLOY PRIMER
| Applicant | Kuraray America, Inc., New York NY, US |
| Decision | Substantially Equivalent, Dec 17, 1997 |
| Received | Oct 29, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974089
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.