510(k) K081078 ยท DZE Implant, Endosseous, Root-Form
NT/IT SYSTEM
| Applicant | Osstem Implant Co., Ltd., Fairless Hills PA, US |
| Decision | Substantially Equivalent, Jul 15, 2008 |
| Received | Apr 16, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081078
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.