510(k) K970848 ยท KLE Agent, Tooth Bonding, Resin
SILOC SYSTEM
| Applicant | Heraeus Kulzer, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, May 6, 1997 |
| Received | Mar 7, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970848
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.