510(k) K992985 ยท KLE Agent, Tooth Bonding, Resin
GLUMA COMFORT BOND
| Applicant | Heraeus Kulzer, Inc., South Bend IN, US |
| Decision | Substantially Equivalent, Oct 14, 1999 |
| Received | Sep 3, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K992985
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.