Hiossen

Also known as: Hiossen Implant, Hiossen, Inc.

The brand under which Osstem Implant sells its implants in the United States, established in Pennsylvania in 2006.

Key facts

Manufacturer	Osstem Implant Co., Ltd.Verified spec[1][2]
Parent company	Osstem Implant Co., Ltd., South KoreaVerified spec[1]
Country	United StatesVerified spec[1]
Headquarters	85 Ben Fairless Drive, Fairless Hills, Pennsylvania, United StatesVerified spec[1]
Founded	2006, in Pennsylvania, established by its parent company OsstemVerified spec[1]
Ownership	Established by, and part of, Osstem ImplantVerified spec[1][2]
manufacturingCountry	United StatesVerified spec[3]Country of the FDA-registered device establishment, which may differ from the brand’s home country.

Overview

Hiossen is not a separate manufacturer; it is the name Osstem Implant uses in the United States, established in Pennsylvania in 2006. Comparison articles that rank Hiossen against Osstem are therefore comparing a company with itself. The distinction that does matter is regulatory and commercial rather than technical: implants sold under the Hiossen name are cleared and supported through the United States organisation, which affects which components a US clinician can readily obtain. For a patient treated abroad with an Osstem implant and later seeking maintenance in another country, the parent-company relationship is the useful fact to have on record.

Regulatory record

Read this before drawing conclusions. A clearance or certificate means a device may legally be sold in a market. It is not a finding that the implant performs well, and it is not a comparison against other implants. In particular, FDA "clearance" is not FDA "approval" — clearance means the FDA accepted the device as substantially equivalent to one already on the market. What these actually mean →

FDA 510(k) clearance3 records

Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.

Number	Device	Holder	Date
K241003	HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)	Hiossen, Inc.	2025-01-08
K140934	HIOSSEN IMPLANT SYSTEM	Hiossen, Inc.	2014-11-12
K140507	HIOSSEN PROSTHETIC SYSTEM	Osstem Implant Co., Ltd.	2014-08-20

Other2 records

Registered device establishment in United States. Registration records where a device is made or handled; it is not a clearance, an approval, or any assessment of the product.

Number	Device	Holder	Date
3007135442	—	HIOSSEN INC.	—
1257 device records	—	Hiossen	—

Clearance records for Hiossen were retrieved from the issuing authority's own database, not from the manufacturer's marketing material. We attribute a clearance to a brand only when the filing holder belongs to that brand's corporate family — third-party clearances for compatible components are excluded, because they belong to the company that made the component, not to Hiossen.

Sources

Numbers match the citations beside each claim above.

Primary sources

[1]About Us — Hiossen Implant — Hiossen, Inc.. Accessed 2026-07-21.
[2]About us — Osstem Implant — Osstem Implant Co., Ltd.. Accessed 2026-07-21.
[3]openFDA — Device registrations and listings — US Food and Drug Administration. Accessed 2026-07-22.