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Hiossen Inc.

FDA Regulatory Profile

Hiossen Inc. has 7 FDA recalls, 8 inspections, 26 510(k) clearances and 1 compliance action on record.

Latest recall
Z-1274-2025 · Class II · Jan 27, 2025
Latest inspection
Jul 23, 2025 · VAI
Latest 510(k)
May 14, 2026

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls7Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances26Nov 8, 2026File dated Nov 2, 2026Current
Inspections8Nov 10, 2026Newest record Nov 5, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

Recent Recalls

NumberClassProductDate
Z-1274-2025Class IIOsstem Implant System - Abutment ET Multi Abutment Size: 4.8D 3.0G/H- Abutment is intended for use…Jan 27, 2025
Z-1276-2025Class IIOsstem Implant System - Abutment: ET Multi AbutmentSize: 4.8D 5.0GH - Abutment is intended for use…Jan 27, 2025
Z-1272-2025Class IIET Rigid Abutment (Mini) SIze: 4.5D 3.0G/H 7.0H - Intended for use with a dental implant to provide…Jan 27, 2025
Z-1271-2025Class IIET Rigid Abutment (Mini) Size 4.5D 1.0G/H 5.0H - Intended for use with a dental implant to provide…Jan 27, 2025
Z-1273-2025Class IIET Rigid Abutment (Mini) SIze: 4.5D 4.0G/H 4.0H - Intended for use with a dental implant to provide…Jan 27, 2025
Z-1275-2025Class IIET Rigid Abutment (Mini) Size: 4.5D 2.0G/H 4.0H- Intended for use with a dental implant to provide…Jan 27, 2025
Z-1604-2023Class IIET III Nano-HA fixture System ET NH Dental Implant Model # ET3R5010B -Intended for Dental Implant…Apr 6, 2023

Recent FDA Inspections

DateSiteProductClassificationFEI
Jul 23, 2025Fairless Hills, PADevicesVoluntary Action Indicated (VAI)3007135442
Aug 20, 2021Norwood, NJBiologicsNo Action Indicated (NAI)3010185635
Feb 20, 2018Norwood, NJBiologicsNo Action Indicated (NAI)3010185635
Apr 24, 2017Norwood, NJDevicesNo Action Indicated (NAI)3010185635
Apr 12, 2017Fairless Hills, PADevicesVoluntary Action Indicated (VAI)3007135442
Mar 23, 2016Norwood, NJBiologicsNo Action Indicated (NAI)3010185635
Apr 18, 2013Fairless Hills, PADevicesVoluntary Action Indicated (VAI)3007135442
May 16, 2012Fairless Hills, PADevicesOfficial Action Indicated (OAI)3007135442

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 3007135442Fairless Hills, PA4Jul 23, 2025
FEI 3010185635Norwood, NJ4Aug 20, 2021

Recent 510(k) Clearances

K-NumberDeviceDate
K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsMay 14, 2026
K251427EK MULTI ANGLED 30 ABUTMENTJan 29, 2026
K241003HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)Jan 8, 2025
K240232EK D3.3 and Ultra Wide ImplantsSep 13, 2024
K233389EK Digital AbutmentsMay 29, 2024
K222636ET Abutment SystemApr 28, 2023
K203360EK Implants and Abutments SystemJan 7, 2022
K191751EM ProvisionalDec 16, 2019
K191201EM SA Implant SystemNov 15, 2019
K183242ET IV SA Dental ImplantsMay 21, 2019
K180527IS3May 16, 2018
K170421ET Hybrid AbutmentJan 11, 2018
K162390ET Hybrid AbutmentJan 30, 2017
K153332ETIII SA Fixture System (O3.2mm)Oct 27, 2016
K151542A-OssAug 3, 2016
K151626ET III Bio-SA Fixture SystemJul 21, 2016
K140934HIOSSEN IMPLANT SYSTEMNov 12, 2014
K132067MULTI ANGLED ABUTMENT SYSTEMDec 20, 2013
K123471ETII SA FIXTURE SYSTEMJul 5, 2013
K123627ET SMARTFIT ABUTMENTJun 28, 2013

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.