510(k) K153521 ยท DZE Implant, Endosseous, Root-Form
IH Implant System
| Applicant | Sewonmedix, Inc., Busan, KR |
| Decision | Substantially Equivalent, Oct 14, 2016 |
| Received | Dec 8, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153521
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.