510(k) K964038 ยท KLE Agent, Tooth Bonding, Resin
CHARISMA F, CHARISMA CREACTIVE, SOLID BOND, & ESTICID -20FG
| Applicant | Heraeus Kulzer, Inc., South Bend IN, US |
| Decision | Substantially Equivalent, Apr 2, 1997 |
| Received | Oct 4, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964038
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.