Warantec

Also known as: Warantec Co., Ltd.

A South Korean implant manufacturer founded in 2001, developer of the Oneplant and IU implant systems, part-owned by Yuhan Corporation and the Straumann Group.

Key facts

Manufacturer	Warantec Co., Ltd.Verified spec[1]
Country	South KoreaVerified spec[1]
Headquarters	Seongnam, Gyeonggi-do, South Korea (Jungwon-gu), per its US regulatory filingsVerified spec[1]
Founded	2001Verified spec[3]
Ownership	Owned by Yuhan Corporation and around 100 dentists; the Straumann Group took a 33.5% shareholding and exclusive distribution rights outside Korea in 2019Verified spec[3]
manufacturingCountry	South KoreaVerified spec[2]Country of the FDA-registered device establishment, which may differ from the brand’s home country.

Overview

Warantec is unusual among Korean implant companies in its origins: it grew out of a 1990s Korean government (G7) research project involving professors at Seoul National, Yonsei and Catholic universities, and was incorporated in 2001. In 2019 the Straumann Group took a 33.5% stake and the rights to sell Warantec outside Korea, alongside majority owner Yuhan Corporation, a large Korean pharmaceutical company. Its long-running product is the Oneplant system; the FDA-cleared IU Implant System is a separate, later line. The Straumann investment is a distribution and ownership fact, not a statement that the products are equivalent to Straumann’s own premium lines.

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) clearance4 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
K221972	Warantec Custom Abutment	Warantec Co., Ltd.	2023-10-02
K221969	IU Implant System Abutment	Warantec Co., Ltd.	2023-05-12
K172345	IU Implant System	Warantec Co., Ltd.	2018-06-18
K081748	ONEPLANT DENTAL IMPLANT SYSTEM	Warantec Co., Ltd.	2009-03-27

Other1 record

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
3009514134	—	WARANTEC Co., Ltd.	—

Clearance records for Warantec 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 Warantec.

Sources

Numbers match the citations beside each claim above.

Primary sources

[1]FDA 510(k) K172345 — IU Implant System — U.S. Food & Drug Administration, 2018. Accessed 2026-07-21.
[2]openFDA — Device registrations and listings — US Food and Drug Administration. Accessed 2026-07-22.

Additional references

[3]Straumann Group partners with Korea’s leading pharmaceutical corporation to drive international expansion of Warantec dental implants — Straumann Group, 2019. Accessed 2026-07-21.