510(k) K151626 ยท DZE Implant, Endosseous, Root-Form
ET III Bio-SA Fixture System
| Applicant | Hiossen, Inc., Fariless Hills PA, US |
| Decision | Substantially Equivalent, Jul 21, 2016 |
| Received | Jun 17, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151626
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 18, 2023 | Hiossen Inc. ET III Nano-HA fixture System ET NH Dental Implant Model # ET3R5010B -Intended for Dental Implant
Catalog #: AET3R5010B Open, Classified |
DZE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.