Manufacturer registered with FDA
Dexcowin Co., Ltd.
Seoul, South Korea. Lists 3 dental device types with FDA across 1 registered establishment, and holds 4 510(k) clearances as applicant.
- Device types listed
- 3
- Brands and models
- 12
- 510(k) clearances
- 42009–2017
- Markets registered in
- 915 registrations outside the US
- Establishments
- 1South Korea
510(k) clearances per year, 2000–2026
Registered in 9 markets
Where regulators' registries name Dexcowin 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 | Dexcowin Co., Ltd. | 4 clearances | 2009–2017 | Below |
| European Union | EUDAMED | Manufacturer | Dexcowin | 5 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Dexcowin Co Ltd | 2 | 2016–2021 | Pure Global AI |
| Canada | Health Canada | Registration holder | DEXCOWIN CO., LTD. | 2 | 2014–2015 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | DEXCOWIN.Co.,Ltd | 2 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | DEXCOWIN CO., LTD. | 1 | 2026–2026 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Dexcowin Co., Ltd | 1 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | DEXCOWIN CO., LTD. | 1 | 2019–2019 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | DEXCOWIN CO., LTD. | 1 | 2008–2008 | 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 Dexcowin 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 |
|---|---|---|---|---|
| Digital Extraoral Source X-Ray SystemMUH · Class 2 | Dental X-ray units | Maker | ADX 4000Cocoon DX-7017Cocoon DX-7020COCOON SOLO (DX-7020s)CS 2500PDX3000iRay D3iRay D4Rex 2 | 2014 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Lister | Tiggle | 2015 |
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Maker | iCam PlusRayCam | 2014 |
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 Dexcowin Co., Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 26 Oct 2017 | K173046 | Cocoon Portable Handheld X-Ray System | MUH Digital Extraoral Source X-Ray System |
| 9 May 2014 | K134055 | ADX4000W | MUH Digital Extraoral Source X-Ray System |
| 24 Apr 2014 | K133007 | DX3000-L | MUH Digital Extraoral Source X-Ray System |
| 10 Mar 2009 | K083532 | ADX4000-L, DX3000-L | MUH Digital Extraoral Source X-Ray System |
Some of these clearances are listed with FDA today by another company: Carestream Dental LLC (1).
Also lists devices cleared under other names
Dexcowin Co., Ltd. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Dexcowin Global, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 24 Oct 2025 | K250687 | Cocoon Solo (DX-7020s) | Dexcowin Global, Inc. | MUH Digital Extraoral Source X-Ray System |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DEXCOWIN CO., LTD.FDA reg. 3007065358 | Seoul, South Korea | Foreign exporter, Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10025963). 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.