510(k) K083652 ยท KLE Agent, Tooth Bonding, Resin
IBOND TOTAL ETCH
| Applicant | Heraeus Kulzer,GmbH, South Bend IN, US |
| Decision | Substantially Equivalent, Jan 21, 2009 |
| Received | Dec 9, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083652
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.