Osstem Implant
Also known as: Osstem Implant Co., Ltd., Osstem
The South Korean dental implant manufacturer behind the Osstem and Hiossen brands; it was delisted from the KOSDAQ market in 2023 following a private-equity takeover.
Key facts
| Headquarters | Seoul, South Korea, with a manufacturing headquarters in BusanVerified spec[1] |
|---|---|
| Country | South KoreaVerified spec[1] |
| Founded | 1997Verified spec[1] |
| Ownership | Private since 2023. Osstem Implant was delisted from Korea’s KOSDAQ market with effect from 14 August 2023, after Dentistry Investment, a consortium of private-equity firms, built a holding of about 96% of the sharesVerified spec[4]Reported by the financial press rather than a company filing available to us; the current shareholder split within the consortium is not verified here |
| Brand | Sold as Osstem in most markets and as Hiossen in the United StatesVerified spec[1][2] |
| Geographic availability | Subsidiaries across more than 90 countriesManufacturer-reported[1] |
| manufacturingCountry | South KoreaVerified spec[3]Country of the FDA-registered device establishment, which may differ from the brand’s home country. |
Overview
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) clearance46 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 |
|---|---|---|---|
| K251434 | Healing Abutment System | Osstem Implant Co., Ltd. | 2026-03-04 |
| K233194 | TS Abutment System | Osstem Implant Co., Ltd. | 2024-02-20 |
| K232220 | SS Abutment System | Osstem Implant Co., Ltd. | 2023-12-05 |
| K222778 | Osstem Implant System | Osstem Implant Co., Ltd. | 2023-09-23 |
| K221684 | Osstem Abutment System | Osstem Implant Co., Ltd. | 2022-09-08 |
| K182091 | Osstem Abutment System | Osstem Implant Co., Ltd. | 2019-07-12 |
| K161689 | OSSTEM Implant System - Abutment | Osstem Implant Co., Ltd. | 2017-05-22 |
| K163557 | SS SA Fixture | Osstem Implant Co., Ltd. | 2017-05-15 |
| K160670 | ET US SS Prosthetic system | Osstem Implant Co., Ltd. | 2017-04-25 |
| K163088 | TSIII BA Fixture | Osstem Implant Co., Ltd. | 2017-04-21 |
| K161103 | US SA Implant System | Osstem Implant Co., Ltd. | 2017-02-02 |
| K153015 | Transfer & Angled Abutment | Osstem Implant Co., Ltd. | 2016-12-05 |
| K160519 | Link Abutment for CEREC | Osstem Implant Co., Ltd. | 2016-10-28 |
| K161604 | OSSTEM Implant System | Osstem Implant Co., Ltd. | 2016-10-17 |
| K140600 | SB ANCHOR | Osstem Implant Co., Ltd. | 2014-08-21 |
| K140507 | HIOSSEN PROSTHETIC SYSTEM | Osstem Implant Co., Ltd. | 2014-08-20 |
| K130662 | ET PROSTHETIC SYSTEM | Osstem Implant Co., Ltd. | 2014-01-10 |
| K123755 | MULTI ANGLED ABUTMENT | Osstem Implant Co., Ltd. | 2013-04-26 |
| K121585 | TS IMPLANT SYSTEM | Osstem Implant Co., Ltd. | 2013-01-07 |
| K121843 | NP-CAST ABUTMENT SYSTEM | Osstem Implant Co., Ltd. | 2012-12-11 |
| K121995 | TS FIXTURE SYSTEM | Osstem Implant Co., Ltd. | 2012-11-29 |
| K122171 | MS SA IMPLANT SYSTEM | Osstem Implant Co., Ltd. | 2012-11-16 |
| K120847 | ET/SS IMPLANT SYSTEM | Osstem Implant Co., Ltd. | 2012-08-10 |
| K110308 | PROSTHETIC SYSTEM | Osstem Implant Co., Ltd. | 2011-10-03 |
| K100245 | HS/HG PROSTHETIC SYSTEM | Osstem Implant Co., Ltd. | 2010-08-17 |
| K091208 | GS III SYSTEM | Osstem Implant Co., Ltd. | 2010-03-03 |
| K091678 | HG II SHORT FIXTURE SYSTEM | Osstem Implant Co., Ltd. | 2010-02-18 |
| K083633 | HS II SHORT FIXTURE SYSTEM | Osstem Implant Co., Ltd. | 2009-05-01 |
| K083067 | MS SYSTEM | Osstem Implant Co., Ltd. | 2009-02-02 |
| K081786 | ZIOCERA & CONVERTIBLE SYSTEM | Osstem Implant Co., Ltd. | 2008-12-02 |
| K082213 | GS III FIXTURE SYSTEM | Osstem Implant Co., Ltd. | 2008-10-14 |
| K080594 | MS SYSTEM (NARROW RIDGE) | Osstem Implant Co., Ltd. | 2008-09-03 |
| K081575 | HU/HS/HG PROSTHETIC SYSTEM | Osstem Implant Co., Ltd. | 2008-09-02 |
| K080744 | HG II FIXTURE SYSTEM | Osstem Implant Co., Ltd. | 2008-07-17 |
| K081078 | NT/IT SYSTEM | Osstem Implant Co., Ltd. | 2008-07-15 |
| K073465 | US/GS ULTRA WIDE SYSTEM | Osstem Implant Co., Ltd. | 2008-04-07 |
| K080387 | HU II / HS II FIXTURE SYSTEM | Osstem Implant Co., Ltd. | 2008-03-07 |
| K073247 | US/SS/GS SYSTEM | Osstem Implant Co., Ltd. | 2008-03-07 |
| K072959 | MS SYSTEM (DENTURE) | Osstem Implant Co., Ltd. | 2008-02-04 |
| K072871 | MS SYSTEM (PROVISIONAL) | Osstem Implant Co., Ltd. | 2008-01-10 |
Showing the 40 most recent of 46. The full set is searchable in the authority's own database.
Other3 records
Registered device establishment in South Korea. 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 |
|---|---|---|---|
| 3031886796 | — | OSSTEM IMPLANT CO., LTD. | — |
| 3003394081 | — | OSSTEM IMPLANT CO., LTD. | — |
| 2157 device records | — | Osstem Implant | — |
Clearance records for Osstem Implant 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 Osstem Implant.
Sources
Numbers match the citations beside each claim above.
Primary sources
- [1]About us — Osstem Implant — Osstem Implant Co., Ltd.. Accessed 2026-07-21.
- [2]About Us — Hiossen Implant — Hiossen, Inc.. Accessed 2026-07-21.
- [3]openFDA — Device registrations and listings — US Food and Drug Administration. Accessed 2026-07-22.
Additional references
- [4]Osstem Implant to be delisted from Kosdaq — The Korea Herald, 2023. Accessed 2026-07-21.