Hiossen, Inc.
Hiossen, Inc. holds FDA 510(k) medical device clearances, first cleared 2009, most recent 2026, with 7 FDA device recalls on record.
Top product codes for Hiossen, Inc.
FDA recalls by Hiossen, Inc.
- Z-1273-2025 — 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: ETRGA4544MP
- Z-1274-2025 — 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 overdentures. Model/Catalog Number: ETMTA503RV1
- Z-1271-2025 — 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 Number: ETRGA4515MP
- Z-1275-2025 — 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: ETRGA4524MP
- Z-1276-2025 — 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 overdentures. Model/Catalog Number: ETMTA505RV1
- Z-1272-2025 — 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: ETRGA4537MP
- Z-1604-2023 — ET III Nano-HA fixture System ET NH Dental Implant Model # ET3R5010B -Intended for Dental Implant Catalog #: AET3R5010B
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Hiossen, Inc.
- K253372 — ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments
- K251427 — EK MULTI ANGLED 30 ABUTMENT
- K241003 — HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)
- K240232 — EK D3.3 and Ultra Wide Implants
- K233389 — EK Digital Abutments
- K222636 — ET Abutment System
- K203360 — EK Implants and Abutments System
- K191751 — EM Provisional
- K191201 — EM SA Implant System
- K183242 — ET IV SA Dental Implants
- K180527 — IS3
- K170421 — ET Hybrid Abutment
- K162390 — ET Hybrid Abutment
- K153332 — ETIII SA Fixture System (O3.2mm)
- K151542 — A-Oss
- K151626 — ET III Bio-SA Fixture System
- K140934 — HIOSSEN IMPLANT SYSTEM
- K132067 — MULTI ANGLED ABUTMENT SYSTEM
- K123471 — ETII SA FIXTURE SYSTEM
- K123627 — ET SMARTFIT ABUTMENT
- K112532 — ET II BIO-SA FIXTURE SYSTEM
- K103537 — ET III SA ULTRA WIDE SYSTEM
- K101096 — HT III SA FIXTURE SYSTEM
- K093889 — MODIFICATION TO: HG III ULTRA WIDE SYSTEM
- K093352 — HG III FIXTURE SYSTEM
- K090237 — HG II FIXTURE SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.