510(k) K080387 ยท DZE Implant, Endosseous, Root-Form
HU II / HS II FIXTURE SYSTEM
| Applicant | Osstem Implant Co., Ltd., Fairless PA, US |
| Decision | Substantially Equivalent, Mar 7, 2008 |
| Received | Feb 13, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K080387
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.