Hiossen Inc.
Summary
- Total Recalls
- 7
- 510(k) Clearances
- 25
- Inspections
- 8
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1273-2025 | Class II | ET Rigid Abutment (Mini) SIze: 4.5D 4.0G/H 4.0H - Intended for use with a dental implant to provide | January 27, 2025 |
| Z-1271-2025 | Class II | ET Rigid Abutment (Mini) Size 4.5D 1.0G/H 5.0H - Intended for use with a dental implant to provide | January 27, 2025 |
| Z-1276-2025 | Class II | Osstem Implant System - Abutment: ET Multi AbutmentSize: 4.8D 5.0GH - Abutment is intended for use | January 27, 2025 |
| Z-1274-2025 | Class II | Osstem Implant System - Abutment ET Multi Abutment Size: 4.8D 3.0G/H- Abutment is intended for use | January 27, 2025 |
| Z-1272-2025 | Class II | ET Rigid Abutment (Mini) SIze: 4.5D 3.0G/H 7.0H - Intended for use with a dental implant to provide | January 27, 2025 |
| Z-1275-2025 | Class II | ET Rigid Abutment (Mini) Size: 4.5D 2.0G/H 4.0H- Intended for use with a dental implant to provide s | January 27, 2025 |
| Z-1604-2023 | Class II | ET III Nano-HA fixture System ET NH Dental Implant Model # ET3R5010B -Intended for Dental Implant C | April 6, 2023 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K251427 | EK MULTI ANGLED 30 ABUTMENT | January 29, 2026 |
| K241003 | HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment) | January 8, 2025 |
| K240232 | EK D3.3 and Ultra Wide Implants | September 13, 2024 |
| K233389 | EK Digital Abutments | May 29, 2024 |
| K222636 | ET Abutment System | April 28, 2023 |
| K203360 | EK Implants and Abutments System | January 7, 2022 |
| K191751 | EM Provisional | December 16, 2019 |
| K191201 | EM SA Implant System | November 15, 2019 |
| K183242 | ET IV SA Dental Implants | May 21, 2019 |
| K180527 | IS3 | May 16, 2018 |
| K170421 | ET Hybrid Abutment | January 11, 2018 |
| K162390 | ET Hybrid Abutment | January 30, 2017 |
| K153332 | ETIII SA Fixture System (O3.2mm) | October 27, 2016 |
| K151542 | A-Oss | August 3, 2016 |
| K151626 | ET III Bio-SA Fixture System | July 21, 2016 |
| K140934 | HIOSSEN IMPLANT SYSTEM | November 12, 2014 |
| K132067 | MULTI ANGLED ABUTMENT SYSTEM | December 20, 2013 |
| K123471 | ETII SA FIXTURE SYSTEM | July 5, 2013 |
| K123627 | ET SMARTFIT ABUTMENT | June 28, 2013 |
| K112532 | ET II BIO-SA FIXTURE SYSTEM | August 6, 2012 |