IDIS
Also known as: IDIS Co., Ltd.
A South Korean implant manufacturer, maker of the S-Plant dental implant system.
Key facts
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) clearance1 record
Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.
| Number | Device | Holder | Date |
|---|---|---|---|
| K231429 | S-Plant Dental Implant System | Idis Co., Ltd. | 2023-12-18 |
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 |
|---|---|---|---|
| 3026365523 | — | IDIS CO., LTD. | — |
Clearance records for IDIS 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 IDIS.
Sources
Numbers match the citations beside each claim above.
Primary sources
- [1]FDA 510(k) K221866 — S-Plant Dental Implant System — U.S. Food & Drug Administration, 2023. Accessed 2026-07-21.
- [2]openFDA — Device registrations and listings — US Food and Drug Administration. Accessed 2026-07-22.