Medical Device Manufacturer · US , Fariless Hills , PA

Hiossen, Inc. - FDA 510(k) Cleared Devices

25 submissions · 25 cleared · Since 2009
25
Total
25
Cleared
0
Denied

Hiossen, Inc. has 25 FDA 510(k) cleared dental devices. Based in Fariless Hills, US.

Latest FDA clearance: Jan 2026. Active since 2009.

Browse the complete list of FDA 510(k) cleared dental devices from this manufacturer. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by IZiel Healthcare as regulatory consultant.

FDA 510(k) Regulatory Record - Hiossen, Inc.
25 devices
1-25 of 25
Cleared Jan 29, 2026
EK MULTI ANGLED 30 ABUTMENT
K251427 · NHA
Dental · 266d
Cleared Jan 08, 2025
HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)
K241003 · NHA
Dental · 271d
Cleared Sep 13, 2024
EK D3.3 and Ultra Wide Implants
K240232 · DZE
Dental · 228d
Cleared May 29, 2024
EK Digital Abutments
K233389 · NHA
Dental · 240d
Cleared Apr 28, 2023
ET Abutment System
K222636 · NHA
Dental · 240d
Cleared Jan 07, 2022
EK Implants and Abutments System
K203360 · DZE
Dental · 417d
Cleared Dec 16, 2019
EM Provisional
K191751 · DZE
Dental · 168d
Cleared Nov 15, 2019
EM SA Implant System
K191201 · DZE
Dental · 193d
Cleared May 21, 2019
ET IV SA Dental Implants
K183242 · DZE
Dental · 181d
Cleared May 16, 2018
IS3
K180527 · EKX
Dental · 77d
Cleared Jan 11, 2018
ET Hybrid Abutment
K170421 · NHA
Dental · 332d
Cleared Jan 30, 2017
ET Hybrid Abutment
K162390 · NHA
Dental · 157d
Cleared Oct 27, 2016
ETIII SA Fixture System (O3.2mm)
K153332 · DZE
Dental · 343d
Cleared Aug 03, 2016
A-Oss
K151542 · NPM
Dental · 422d
Cleared Jul 21, 2016
ET III Bio-SA Fixture System
K151626 · DZE
Dental · 400d
Cleared Nov 12, 2014
HIOSSEN IMPLANT SYSTEM
K140934 · DZE
Dental · 215d
Cleared Dec 20, 2013
MULTI ANGLED ABUTMENT SYSTEM
K132067 · NHA
Dental · 170d
Cleared Jul 05, 2013
ETII SA FIXTURE SYSTEM
K123471 · DZE
Dental · 234d
Cleared Jun 28, 2013
ET SMARTFIT ABUTMENT
K123627 · NHA
Dental · 217d
Cleared Aug 06, 2012
ET II BIO-SA FIXTURE SYSTEM
K112532 · DZE
Dental · 341d
Cleared Mar 10, 2011
ET III SA ULTRA WIDE SYSTEM
K103537 · DZE
Dental · 98d
Cleared Oct 08, 2010
HT III SA FIXTURE SYSTEM
K101096 · DZE
Dental · 171d
Cleared Apr 22, 2010
MODIFICATION TO: HG III ULTRA WIDE SYSTEM
K093889 · DZE
Dental · 125d
Cleared Nov 24, 2009
HG III FIXTURE SYSTEM
K093352 · DZE
Dental · 28d
Cleared Apr 17, 2009
HG II FIXTURE SYSTEM
K090237 · DZE
Dental · 74d
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