Warantec
Also known as: Oneplant, IU Implant
The implant brand of Warantec Co., Ltd. of South Korea, covering the Oneplant and IU implant systems.
Key facts
| Manufacturer | Warantec Co., Ltd.Verified spec[1] |
|---|---|
| Country | South KoreaVerified spec[1] |
| Founded | 2001Verified spec[3] |
| Surface | SA (sandblasted and acid-etched) on grade-4 commercially pure titanium (IU Implant System)Verified spec[1] |
| Connection | Internal hex (2.1 / 2.5 mm) on the IU Implant SystemVerified spec[1] |
| manufacturingCountry | South KoreaVerified spec[2]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) clearance3 records
Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.
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.