DIO
Also known as: DIO Corporation, DIO Implant, DSI Co., Ltd.
A South Korean manufacturer in Busan, founded in 1988 and formerly DSI Co., Ltd., maker of the UF(II) and UV Active implant systems and the DIOnavi guided-surgery workflow.
Key facts
| Manufacturer | DIO CorporationVerified spec[1] |
|---|---|
| Country | South KoreaVerified spec[1] |
| Headquarters | Busan, South Korea (66 Centum seo-ro, Haeundae-gu)Verified spec[1][2] |
| Founded | 1988Verified spec[4] |
| Predecessor system | Formerly named DSI Co., Ltd.; renamed DIO Corporation in August 2008Verified spec[4] |
| 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 →
Other2 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 |
|---|---|---|---|
| 3007126709 | — | DIO Corporation | — |
| 1533 device records | — | DIO | — |
Clearance records for DIO 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 DIO.
Sources
Numbers match the citations beside each claim above.
Primary sources
- [1]FDA 510(k) K170608 — UF(II) Implant System — U.S. Food & Drug Administration, 2018. Accessed 2026-07-21.
- [2]FDA 510(k) K182194 — UV Active Implant System — U.S. Food & Drug Administration, 2018. Accessed 2026-07-21.
- [3]openFDA — Device registrations and listings — US Food and Drug Administration. Accessed 2026-07-22.
Additional references
- [4]DIO Corporation (KOSDAQ: 039840) company profile — StockAnalysis. Accessed 2026-07-21.