Manufacturer registered with FDA
WinUs Technology Co., Ltd.
Gun Po Si, South Korea. Lists 1 dental device type with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 1
- Brands and models
- 7
- 510(k) clearances
- 12004–2004
- Markets registered in
- 46 registrations outside the US
- Establishments
- 1South Korea
510(k) clearances per year, 2000–2026
Registered in 4 markets
Where regulators' registries name WinUs Technology Co., Ltd. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | WinUs Technology Co., Ltd. | 1 clearances | 2004–2004 | Below |
| Taiwan | TFDA | Manufacturer | WIN-US TECHNOLOGY CO., LTD.WINUS TECHNOLOGY CO., LTD. | 4 | 2006–2019 | Pure Global AI |
| Australia | TGA | Manufacturer | Winus Technology Co Ltd | 1 | 2017–2017 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | WINUS Technology Co., Ltd | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What WinUs Technology Co., Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Operative Dental UnitEIA · Class 1 | Dental chairs & operative units | Maker | Dexcam3Dexcam4Dexcam4 HDGXC300RaycamRaycam PlusSmartcam | 2009 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names WinUs Technology Co., Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 23 Mar 2004 | K040691 | INTRA ORAL CAMERA SYSTEM & ACCESSORIES, MODEL WIN-100D | EIA Operative Dental Unit |
Some of these clearances are listed with FDA today by another company: Dental Imaging Technologies Corporation (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| WINUS TECHNOLOGY CO., LTD.FDA reg. 3007518359 | Gun Po Si Gyeonggi, South Korea | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10028427). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.