Warantec IU Implant System
Also known as: IU Implant System, Warantec IU
An internal-hex implant from Warantec offered in two thread geometries — a triangular and a square thread — with an SA surface.
Quick facts
| Manufacturer | Warantec Co., Ltd.Verified spec[1] |
|---|---|
| Body geometry | Root-form fixture available in a triangular-thread and a square-thread designVerified spec[1] |
| Thread design | Two options: a triangular screw thread and a square screw threadVerified spec[1] |
| Material | Grade-4 commercially pure titanium (ASTM F67)Verified spec[1] |
| Surface | SA — sandblasted and acid-etchedVerified spec[1] |
| Connection | Internal hex (2.1 and 2.5 mm)Verified spec[1] |
| Available diameters | Triangular thread: Ø3.6, 4.1, 4.6, 5.1, 5.6 and 6.1 mm; square thread: Ø4.3, 4.8, 5.3 and 6.3 mmVerified spec[1] |
| Available lengths | Triangular thread: 7.5, 8.5, 10.0, 11.5 and 13.0 mm (Ø3.6 excludes 7.5 mm); square thread: 7.0, 8.5, 10.0, 11.5 and 13.0 mm (Ø6.3 excludes 13.0 mm)Verified spec[1] |
Overview
Technology
Further detail
| Country | South KoreaVerified spec[1] |
|---|
Clinical evidence
We have not yet completed a system-specific evidence review for Warantec IU Implant System. Insufficient system-specific evidence How we grade evidence
Similar implant systems
The clearances below are held by Warantec at brand level and cover its implant range, not Warantec IU Implant System specifically. We show them here because that is the level at which regulators actually issue them.
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.