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

FDA 510(k) cleared devices by Hiossen, Inc. Dental

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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