Hiossen, Inc.
Medical device manufacturer in Fariless Hills, PA.
26510(k) clearances
0PMA approvals
7recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K253372 | ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsNHA · Traditional | 05/14/2026SE |
| K251427 | Ek Multi Angled 30 AbutmentNHA · Traditional | 01/29/2026SE |
| K241003 | HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)NHA · Abbreviated | 01/08/2025SE |
| K240232 | EK D3.3 and Ultra Wide ImplantsDZE · Traditional | 09/13/2024SE |
| K233389 | EK Digital AbutmentsNHA · Traditional | 05/29/2024SE |
| K222636 | ET Abutment SystemNHA · Traditional | 04/28/2023SE |
| K203360 | EK Implants and Abutments SystemDZE · Traditional | 01/07/2022SE |
| K191751 | EM ProvisionalDZE · Abbreviated | 12/16/2019SE |
| K191201 | EM SA Implant SystemDZE · Traditional | 11/15/2019SE |
| K183242 | ET IV SA Dental ImplantsDZE · Special | 05/21/2019SE |
| K180527 | IS3EKX · Traditional | 05/16/2018SE |
| K170421 | ET Hybrid AbutmentNHA · Traditional | 01/11/2018SE |
| K162390 | ET Hybrid AbutmentNHA · Traditional | 01/30/2017SE |
| K153332 | ETIII SA Fixture System (O3.2mm)DZE · Traditional | 10/27/2016SE |
| K151542 | A-OssNPM · Traditional | 08/03/2016SE |
| K151626 | ET III Bio-SA Fixture SystemDZE · Traditional | 07/21/2016SE |
| K140934 | Hiossen Implant SystemDZE · Traditional | 11/12/2014SE |
| K132067 | Multi Angled Abutment SystemNHA · Special | 12/20/2013SE |
| K123471 | Etii SA Fixture SystemDZE · Traditional | 07/05/2013SE |
| K123627 | Et Smartfit AbutmentNHA · Traditional | 06/28/2013SE |
| K112532 | Et II Bio-Sa Fixture SystemDZE · Traditional | 08/06/2012SE |
| K103537 | Et III SA Ultra Wide SystemDZE · Special | 03/10/2011SE |
| K101096 | HT III SA Fixture SystemDZE · Traditional | 10/08/2010SE |
| K093889 | Modification to: HG III Ultra Wide SystemDZE · Special | 04/22/2010SE |
| K093352 | HG III Fixture SystemDZE · Special | 11/24/2009SE |
| K090237 | HG II Fixture SystemDZE · Traditional | 04/17/2009SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1276-2025 Class II | Osstem Implant System - Abutment: ET Multi AbutmentSize: 4.8D 5.0GH - Abutment is…Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular… | 01/27/2025Open, Classified |
| Z-1275-2025 Class II | ET Rigid Abutment (Mini) Size: 4.5D 2.0G/H 4.0H- Intended for use with a dental implant…Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular… | 01/27/2025Open, Classified |
| Z-1274-2025 Class II | Osstem Implant System - Abutment ET Multi Abutment Size: 4.8D 3.0G/H- Abutment is…Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular… | 01/27/2025Open, Classified |
| Z-1273-2025 Class II | ET Rigid Abutment (Mini) SIze: 4.5D 4.0G/H 4.0H - Intended for use with a dental implant…Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular… | 01/27/2025Open, Classified |
| Z-1272-2025 Class II | ET Rigid Abutment (Mini) SIze: 4.5D 3.0G/H 7.0H - Intended for use with a dental implant…Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular… | 01/27/2025Open, Classified |
| Z-1271-2025 Class II | ET Rigid Abutment (Mini) Size 4.5D 1.0G/H 5.0H - Intended for use with a dental implant…Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular… | 01/27/2025Open, Classified |
| Z-1604-2023 Class II | ET III Nano-HA fixture System ET NH Dental Implant Model # ET3R5010B -Intended for…Mis-labeled length of the dental implant on the Recall Implant's package. Dental implant size D5.0 x L8.5mm… | 04/06/2023Open, Classified |