Data / Medical devices / United States / Hiossen Inc.
Hiossen Inc.: FDA-registered device maker in Fairless Hills, PA, United States, 23 510(k) clearances
Hiossen Inc. is registered with the FDA (registration 3007135442) in Fairless Hills, PA, United States. It lists 4 device types. The FDA files 23 510(k) clearances under its listings, the newest dated May 14, 2026. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007135442
- Address
- 85 Ben Fairless DR, Fairless Hills, PA, United States, 19030
- Owner or operator
- Hiossen Inc. (10026425)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler
- First device listed
- May 2, 2011
- Registered through
- 2026
- Brand names listed
- 3D LAB ANALOG, A-Graft, Bite Impression Coping Driver, Bushing, Convertible Lab Analog, Convertible Pick-Up Guide Pin, Convertible Pick-Up Impression Coping, Convertible Polishing Protector and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Bone Grafting Material, Animal Source | NPM | 2 | Manufacturer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 14, 2026 | K253372 | ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments | NHA | Substantially Equivalent | Hiossen, Inc. | accessdata.fda.gov |
| January 29, 2026 | K251427 | EK MULTI ANGLED 30 ABUTMENT | NHA | Substantially Equivalent | Hiossen, Inc. | accessdata.fda.gov |
| January 8, 2025 | K241003 | HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment) | NHA | Substantially Equivalent | Hiossen, Inc. | accessdata.fda.gov |
| September 13, 2024 | K240232 | EK D3.3 and Ultra Wide Implants | DZE | Substantially Equivalent | Hiossen, Inc. | accessdata.fda.gov |
| May 29, 2024 | K233389 | EK Digital Abutments | NHA | Substantially Equivalent | Hiossen, Inc. | accessdata.fda.gov |
| February 20, 2024 | K233194 | TS Abutment System | NHA | Substantially Equivalent | Osstem Implant Co., Ltd. | accessdata.fda.gov |
| April 28, 2023 | K222636 | ET Abutment System | NHA | Substantially Equivalent | Hiossen, Inc. | accessdata.fda.gov |
| January 7, 2022 | K203360 | EK Implants and Abutments System | DZE | Substantially Equivalent | Hiossen, Inc. | accessdata.fda.gov |
| December 16, 2019 | K191751 | EM Provisional | DZE | Substantially Equivalent | Hiossen, Inc. | accessdata.fda.gov |
| November 15, 2019 | K191201 | EM SA Implant System | DZE | Substantially Equivalent | Hiossen, Inc. | accessdata.fda.gov |
| July 12, 2019 | K182091 | Osstem Abutment System | NHA | Substantially Equivalent | Osstem Implant Co., Ltd. | accessdata.fda.gov |
| May 21, 2019 | K183242 | ET IV SA Dental Implants | DZE | Substantially Equivalent | Hiossen, Inc. | accessdata.fda.gov |
| January 11, 2018 | K170421 | ET Hybrid Abutment | NHA | Substantially Equivalent | Hiossen, Inc. | accessdata.fda.gov |
| May 22, 2017 | K161689 | OSSTEM Implant System - Abutment | NHA | Substantially Equivalent | Osstem Implant Co., Ltd. | accessdata.fda.gov |
| October 27, 2016 | K153332 | ETIII SA Fixture System (O3.2mm) | DZE | Substantially Equivalent | Hiossen, Inc. | accessdata.fda.gov |
| August 3, 2016 | K151542 | A-Oss | NPM | Substantially Equivalent | Hiossen, Inc. | accessdata.fda.gov |
| July 21, 2016 | K151626 | ET III Bio-SA Fixture System | DZE | Substantially Equivalent | Hiossen, Inc. | accessdata.fda.gov |
| November 12, 2014 | K140934 | HIOSSEN IMPLANT SYSTEM | DZE | Substantially Equivalent | Hiossen, Inc. | accessdata.fda.gov |
| August 20, 2014 | K140507 | HIOSSEN PROSTHETIC SYSTEM | NHA | Substantially Equivalent | Osstem Implant Co., Ltd. | accessdata.fda.gov |
| July 5, 2013 | K123471 | ETII SA FIXTURE SYSTEM | DZE | Substantially Equivalent | Hiossen, Inc. | accessdata.fda.gov |
| June 28, 2013 | K123627 | ET SMARTFIT ABUTMENT | NHA | Substantially Equivalent | Hiossen, Inc. | accessdata.fda.gov |
| October 3, 2011 | K110308 | PROSTHETIC SYSTEM | NHA | Substantially Equivalent | Osstem Implant Co., Ltd. | accessdata.fda.gov |
| March 7, 2008 | K073247 | US/SS/GS SYSTEM | DZE | Substantially Equivalent | Osstem Implant Co., Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 27, 2025 | 96178 | Class II | Ongoing | ET Rigid Abutment (Mini) Size 4.5D 1.0G/H 5.0H - Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. GA4515MP Model/Catalog Number: ETRGA4515MP | Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular version whereas the actual product is a Mini version; and identify the ET Multi Abutments as Mini version whereas the actual product is a Regular version | accessdata.fda.gov |
| April 6, 2023 | 92272 | Class II | Ongoing | ET III Nano-HA fixture System ET NH Dental Implant Model # ET3R5010B -Intended for Dental Implant Catalog #: AET3R5010B | Mis-labeled length of the dental implant on the Recall Implant's package. Dental implant size D5.0 x L8.5mm, labeled as D5.0 x L10mm | accessdata.fda.gov |
Compare with other makers
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Bone Grafting Material, Animal Source
- All makers of Implant, Endosseous, Root-Form
- All makers of Accessories, Implant, Dental, Endosseous
Updated May 14, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.