Manufacturer registered with FDA
Hiossen Inc.
Fairless Hills, PA, United States. Lists 11 dental device types with FDA across 4 registered establishments, and holds 26 510(k) clearances as applicant.
- Device types listed
- 11
- Brands and models
- 102
- 510(k) clearances
- 262009–2026
- Markets registered in
- 11128 registrations outside the US
- Establishments
- 4United States
510(k) clearances per year, 2000–2026
Registered in 11 markets
Where regulators' registries name Hiossen Inc. as the manufacturer or the registration holder of a device.
RegisteredHome: United StatesOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Hiossen Inc. | 26 clearances | 2009–2026 | Below |
| Canada | Health Canada | Registration holder | HIOSSEN INC. | 88 | 2011–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | HIOSSEN INC.HIOSSEN, INC. | 9 | 2010–2025 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | HIOSSEN Inc. | 7 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | HIOSSEN Inc.HIOSSEN Inc · Hiossen Inc | 7 | 2009–2019 | Pure Global AI |
| China | NMPA | Registration holder | 皓圣美有限责任公司Hiossen, Inc.皓圣美有限责任公司HIOSSEN, INC. | 6 | — | Pure Global AI |
| Colombia | INVIMA | Registration holder | HIOSSEN INC | 4 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Hiossen Inc | 3 | 2016–2026 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Hiossen Inc. | 2 | 2025–2025 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | HIOSSEN, INC. | 1 | 2026–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | HIOSSEN, Inc. | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Hiossen Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | EK Dental Implants and AbutmentsEK Digital AbutmentsEK Multi Angled 30 Degree AbutmentET Abutment SystemET Angled AbutmentsET Combination Angled CylinderET Convertible Angled CylinderET Esthetic Low Gold CylinderET Esthetic Low Temporary CylinderET Freeform ST Abutments 22 moreET Gold Cast AbutmentsET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsET Hybrid AbutmentET III Fixture Mini SAET III Fixture Regular SAET III SA FixtureET Multi AbutmentsET Multi Angled AbutmentET Multi-Angled AbutmentsET Multi-NP Cast CylinderET NP-Cast AbutmentsET Quick Temporary AbutmentsET Rigid AbutmentsET SMARTFit AbutmentET Stud AbutmentsET Temporary AbutmentsET Transfer AbutmentsET Ziocera AbutmentsET Ziocera Angled AbutmentsETIII SA Fixture System (D3.2)HIOSSEN IMPLANT SYSTEMHIOSSEN Pre-milled Abutment | 2013 |
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | EK D3.3 and Ultra Wide Dental ImplantsEK Dental Implants and AbutmentsEK Multi Angled 30 Degree AbutmentEM ProvisionalEM SA Implant SystemET Esthetic Low Plastic CylinderET III Fixture Mini NHET III Fixture Mini SAET III Fixture Regular NHET III Fixture Regular SA 7 moreET III Nano-HA Fixture SystemET III SA FixtureET IV NH Dental ImplantsET IV SA Dental ImplantsETII SA FIXTURE SYSTEMETIII SA Fixture System (D3.2)HIOSSEN IMPLANT SYSTEM | 2013 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Bite Impression Coping DriverBushingConvertible Lab AnalogConvertible Pick-Up Guide PinConvertible Pick-Up Impression CopingConvertible Polishing ProtectorConvertible Transfer Impression CopingEK Bite Impression CopingEK Digital Lab AnalogEK Lab Analog 33 moreEK Pick Up Impression CopingEK ScanbodyEK Transfer Impression CopingEsthetic Low Lab AnalogEsthetic Low Pick-up Impression CopingEsthetic Low Pick-up Impression Coping Guide PinEsthetic Low Polishing ProtectorEsthetic Low Transfer Impression CopingET Bite Impression CopingET Bite IndexET Digital Lab AnalogET Digital Lab Analog ScrewET Fixture Lab AnalogET Fixture Pick-up Impression CopingET Fixture Transfer Impression CopingET Multi Digital Lab AnalogET Pick-up Guide PinET Rigid Burn-out CylinderET Rigid Impression CopingET Scan BodyET Scan Post - CerecFixture Lab AnalogFixture Pick-up Impression CopingHiossen EbonyGold Abutment ScrewHiossen Ti Abutment ScrewLaboratory Waxing ScrewMulti Scan BodyO-ring Lab AnalogONE GUIDE SURGICAL TEMPLATEPlateRigid Lab AnalogStackable Guide3D LAB ANALOG | 2011 |
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Maker | Smartfit Provisional DentureSmartfit Try In Hybrid Denture | 2025 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | Smartfit Provisional DentureSmartfit Try In Hybrid Denture | 2025 |
| Handpiece and Cord Foot ControllerEBW · Class 1 | — | Lister | SM3 | 2019 |
| Dental Contra- and Right-Angle Attachment HandpieceEGS · Class 1 | Dental handpieces | Lister | SM3 | 2019 |
| Porcelain PowderEIH · Class 2 | Dental ceramics & zirconia | Maker | Smartfit Final Hybrid Denture | 2025 |
| Rotary Bone Cutting HandpieceKMW · Class 2 | Surgical drills & motors | Lister | SM3 | 2019 |
| Preformed Tooth PositionerKMY · Class 1 | Retainers, expanders & headgear | Maker | Tooth Positioner | 2026 |
| Animal Source Bone Grafting MaterialNPM · Class 2 | Bone grafts & membranes | Maker | A-Graft | 2016 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Hiossen Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 14 May 2026 | K253372 | ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments | NHA Endosseous Dental Implant Abutment |
| 29 Jan 2026 | K251427 | EK MULTI ANGLED 30 ABUTMENT | NHA Endosseous Dental Implant Abutment |
| 8 Jan 2025 | K241003 | HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment) | NHA Endosseous Dental Implant Abutment |
| 13 Sep 2024 | K240232 | EK D3.3 and Ultra Wide Implants | DZE Root-Form Endosseous Implant |
| 29 May 2024 | K233389 | EK Digital Abutments | NHA Endosseous Dental Implant Abutment |
| 28 Apr 2023 | K222636 | ET Abutment System | NHA Endosseous Dental Implant Abutment |
| 7 Jan 2022 | K203360 | EK Implants and Abutments System | DZE Root-Form Endosseous Implant |
| 16 Dec 2019 | K191751 | EM Provisional | DZE Root-Form Endosseous Implant |
| 15 Nov 2019 | K191201 | EM SA Implant System | DZE Root-Form Endosseous Implant |
| 21 May 2019 | K183242 | ET IV SA Dental Implants | DZE Root-Form Endosseous Implant |
| 16 May 2018 | K180527 | IS3 | EKX Ac-Powered Direct Drive Handpiece |
| 11 Jan 2018 | K170421 | ET Hybrid Abutment | NHA Endosseous Dental Implant Abutment |
| 30 Jan 2017 | K162390 | ET Hybrid Abutment | NHA Endosseous Dental Implant Abutment |
| 27 Oct 2016 | K153332 | ETIII SA Fixture System (O3.2mm) | DZE Root-Form Endosseous Implant |
| 3 Aug 2016 | K151542 | A-Oss | NPM Animal Source Bone Grafting Material |
| 21 Jul 2016 | K151626 | ET III Bio-SA Fixture System | DZE Root-Form Endosseous Implant |
| 12 Nov 2014 | K140934 | HIOSSEN IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 20 Dec 2013 | K132067 | MULTI ANGLED ABUTMENT SYSTEM | NHA Endosseous Dental Implant Abutment |
| 5 Jul 2013 | K123471 | ETII SA FIXTURE SYSTEM | DZE Root-Form Endosseous Implant |
| 28 Jun 2013 | K123627 | ET SMARTFIT ABUTMENT | NHA Endosseous Dental Implant Abutment |
| 6 Aug 2012 | K112532 | ET II BIO-SA FIXTURE SYSTEM | DZE Root-Form Endosseous Implant |
| 10 Mar 2011 | K103537 | ET III SA ULTRA WIDE SYSTEM | DZE Root-Form Endosseous Implant |
| 8 Oct 2010 | K101096 | HT III SA FIXTURE SYSTEM | DZE Root-Form Endosseous Implant |
| 22 Apr 2010 | K093889 | MODIFICATION TO: HG III ULTRA WIDE SYSTEM | DZE Root-Form Endosseous Implant |
| 24 Nov 2009 | K093352 | HG III FIXTURE SYSTEM | DZE Root-Form Endosseous Implant |
| 17 Apr 2009 | K090237 | HG II FIXTURE SYSTEM | DZE Root-Form Endosseous Implant |
Some of these clearances are listed with FDA today by another company: Osstem Implant Co., Ltd. (14), Digital Age Dental Laboratories, Ltd. (2).
Also lists devices cleared under other names
Hiossen Inc. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Osstem Implant Co., Ltd. (6), Belport Company, Inc., Gingi-Pak (1), DENTALMAX Co., Ltd (1), Nakanishi, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 20 Jun 2024 | K240688 | RODIN Titan 3D Resin | Belport Company, Inc., Gingi-Pak | EBI Rebasing Repairing Relining Denture Resin |
| 20 Feb 2024 | K233194 | TS Abutment System | Osstem Implant Co., Ltd. | NHA Endosseous Dental Implant Abutment |
| 12 Jul 2019 | K182091 | Osstem Abutment System | Osstem Implant Co., Ltd. | NHA Endosseous Dental Implant Abutment |
| 31 Oct 2018 | K171585 | LUXEN Zr, LUXEN Smile | DENTALMAX Co., Ltd | EIH Porcelain Powder |
| 19 Jun 2018 | K173905 | Surgic Pro, Surgic Pro+ | Nakanishi, Inc. | EBW Handpiece and Cord Foot Controller |
| 22 May 2017 | K161689 | OSSTEM Implant System - Abutment | Osstem Implant Co., Ltd. | NHA Endosseous Dental Implant Abutment |
| 20 Aug 2014 | K140507 | HIOSSEN PROSTHETIC SYSTEM | Osstem Implant Co., Ltd. | NHA Endosseous Dental Implant Abutment |
| 3 Oct 2011 | K110308 | PROSTHETIC SYSTEM | Osstem Implant Co., Ltd. | NHA Endosseous Dental Implant Abutment |
| 7 Mar 2008 | K073247 | US/SS/GS SYSTEM | Osstem Implant Co., Ltd. | DZE Root-Form Endosseous Implant |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| HIOSSEN INC.FDA reg. 3007135442 | Fairless Hills, PA, United States | Complaint file establishment, Manufacturer, Repacker / relabeler |
| HIOSSEN INC.FDA reg. 3010185635 | Norwood, NJ, United States | Repacker / relabeler |
| Hiossen, Inc.FDA reg. 3031162123 | Buena Park, CA, United States | Manufacturer |
| HIOSSEN, INC.FDA reg. 3017450159 | Morrisville, PA, United States | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10026425). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.