510(k) K990143 ยท KLE Agent, Tooth Bonding, Resin
GLUMA ONE BOND
| Applicant | Heraeus Kulzer, Inc., South Bend IN, US |
| Decision | Substantially Equivalent, Feb 25, 1999 |
| Received | Jan 19, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K990143
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.