510(k) K161689 ยท NHA Abutment, Implant, Dental, Endosseous
OSSTEM Implant System - Abutment
| Applicant | Osstem Implant Co., Ltd., Busan, KR |
| Decision | Substantially Equivalent, May 22, 2017 |
| Received | Jun 20, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161689
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 5, 2025 | Hiossen Inc. Osstem Implant System - Abutment ET Multi Abutment Size: 4.8D 3.0G/H- Abutment is intended for use with a dental implant to provide suport for prosthetic restorations such as crowns, bridges, or over Open, Classified |
NHA | None listed |
| Mar 5, 2025 | Hiossen Inc. Osstem Implant System - Abutment: ET Multi AbutmentSize: 4.8D 5.0GH - Abutment is intended for use with a dental implant to provide suport for prosthetic restorations such as crowns, bridges, or over Open, Classified |
NHA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.