510(k) K082591 ยท ELW Material, Impression
FLEXITIME BITE
| Applicant | Heraeus Kulzer, Inc., Dental Products Division, South Bend IN, US |
| Decision | Substantially Equivalent, Dec 5, 2008 |
| Received | Sep 8, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082591
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.