510(k) K974390 ยท KLE Agent, Tooth Bonding, Resin
GLUMA ONE BOND
| Applicant | Heraeus Kulzer, Inc., South Bend IN, US |
| Decision | Substantially Equivalent, Feb 4, 1998 |
| Received | Nov 21, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974390
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.