510(k) K181138 ยท DZE Implant, Endosseous, Root-Form
IS-III active System
| Applicant | Neobiotech Co., Ltd., Seoul, KR |
| Decision | Substantially Equivalent, Oct 3, 2018 |
| Received | Apr 30, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181138
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.