Medical Device Manufacturer · US , Fariless Hills , PA

Hiossen, Inc.

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

Hiossen, Inc. — FDA 510(k) Submissions

Hiossen, Inc. has submitted 25 FDA 510(k) premarket notifications since 2009, of which 25 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Implant, Endosseous, Root-form, Abutment, Implant, Dental, Endosseous, Handpiece, Direct Drive, Ac-powered, Bone Grafting Material, Animal Source . Use the specialty filter in the sidebar to narrow results.

25 devices
1–25 of 25
EK MULTI ANGLED 30 ABUTMENT
K251427 · NHA Abutment, Implant,... · Dental
Jan 2026 266d
HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)
K241003 · NHA Abutment, Implant,... · Dental
Jan 2025 271d
EK D3.3 and Ultra Wide Implants
K240232 · DZE Implant, Endosseous,... · Dental
Sep 2024 228d
EK Digital Abutments
K233389 · NHA Abutment, Implant,... · Dental
May 2024 240d
ET Abutment System
K222636 · NHA Abutment, Implant,... · Dental
Apr 2023 240d
EK Implants and Abutments System
K203360 · DZE Implant, Endosseous,... · Dental
Jan 2022 417d
EM Provisional
K191751 · DZE Implant, Endosseous,... · Dental
Dec 2019 168d
EM SA Implant System
K191201 · DZE Implant, Endosseous,... · Dental
Nov 2019 193d
ET IV SA Dental Implants
K183242 · DZE Implant, Endosseous,... · Dental
May 2019 181d
IS3
K180527 · EKX Handpiece, Direct Drive,... · Dental
May 2018 77d
ET Hybrid Abutment
K170421 · NHA Abutment, Implant,... · Dental
Jan 2018 332d
ET Hybrid Abutment
K162390 · NHA Abutment, Implant,... · Dental
Jan 2017 157d
ETIII SA Fixture System (O3.2mm)
K153332 · DZE Implant, Endosseous,... · Dental
Oct 2016 343d
A-Oss
K151542 · NPM Bone Grafting Material,... · Dental
Aug 2016 422d
ET III Bio-SA Fixture System
K151626 · DZE Implant, Endosseous,... · Dental
Jul 2016 400d
HIOSSEN IMPLANT SYSTEM
K140934 · DZE Implant, Endosseous,... · Dental
Nov 2014 215d
MULTI ANGLED ABUTMENT SYSTEM
K132067 · NHA Abutment, Implant,... · Dental
Dec 2013 170d
ETII SA FIXTURE SYSTEM
K123471 · DZE Implant, Endosseous,... · Dental
Jul 2013 234d
ET SMARTFIT ABUTMENT
K123627 · NHA Abutment, Implant,... · Dental
Jun 2013 217d
ET II BIO-SA FIXTURE SYSTEM
K112532 · DZE Implant, Endosseous,... · Dental
Aug 2012 341d
ET III SA ULTRA WIDE SYSTEM
K103537 · DZE Implant, Endosseous,... · Dental
Mar 2011 98d
HT III SA FIXTURE SYSTEM
K101096 · DZE Implant, Endosseous,... · Dental
Oct 2010 171d
MODIFICATION TO: HG III ULTRA WIDE SYSTEM
K093889 · DZE Implant, Endosseous,... · Dental
Apr 2010 125d
HG III FIXTURE SYSTEM
K093352 · DZE Implant, Endosseous,... · Dental
Nov 2009 28d
HG II FIXTURE SYSTEM
K090237 · DZE Implant, Endosseous,... · Dental
Apr 2009 74d
Filters
All25 Dental 25