510(k) K130662 ยท NHA Abutment, Implant, Dental, Endosseous
ET PROSTHETIC SYSTEM
| Applicant | Osstem Implant Co., Ltd., Fariless Hills PA, US |
| Decision | Substantially Equivalent, Jan 10, 2014 |
| Received | Mar 12, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130662
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 5, 2025 | Hiossen Inc. ET Rigid Abutment (Mini) Size 4.5D 1.0G/H 5.0H - Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
GA4515MP
Model/Catalog Open, Classified |
NHA | None listed |
| Mar 5, 2025 | Hiossen Inc. ET Rigid Abutment (Mini) SIze: 4.5D 3.0G/H 7.0H - Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
Model/Catalog Number: Open, Classified |
NHA | None listed |
| Mar 5, 2025 | Hiossen Inc. ET Rigid Abutment (Mini) SIze: 4.5D 4.0G/H 4.0H - Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
Model/Catalog Number: Open, Classified |
NHA | None listed |
| Mar 5, 2025 | Hiossen Inc. ET Rigid Abutment (Mini) Size: 4.5D 2.0G/H 4.0H- Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
Model/Catalog Number: E Open, Classified |
NHA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.