Data / Medical devices / South Korea / Dexcowin Co., Ltd.

Dexcowin Co., Ltd.: FDA-registered device maker in Seoul, South Korea, 6 510(k) clearances

Name: Dexcowin Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Dexcowin Co., Ltd. is registered with the FDA (registration 3007065358) in Seoul, South Korea. It lists 6 device types. The FDA files 6 510(k) clearances under its listings, the newest dated October 24, 2025. Registered through 2027. FDA data exported November 3, 2026.

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FDA registration number: 3007065358
Address: 25, Gasan digital 1-ro Geumcheon-gu, Seoul, South Korea, 08594
Owner or operator: Dexcowin Co., Ltd. (10025963)
Roles: Exporter to the US, Manufacturer, Repackager or relabeler
First device listed: November 7, 2014
Registered through: 2027
Brand names listed: ADX 4000, ADX6000, ADX6000s, AllMy T Stand, COCOON SOLO (DX-7020s), CS 2500P, Cocoon DX-7017, Cocoon DX-7020 and more

Devices it lists

Device	Product code	Class	Role	Source
Bracket, Metal, Orthodontic	EJF	1	Exporter to the US	accessdata.fda.gov
Solid State X-Ray Imager (Flat Panel/Digital Imager)	MQB	2	Repackager or relabeler	accessdata.fda.gov
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	NOF	2	Manufacturer	accessdata.fda.gov
System, X-Ray, Extraoral Source, Digital	MUH	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
System, X-Ray, Mobile	IZL	2	Manufacturer	accessdata.fda.gov
Tube Mount, X-Ray, Diagnostic	IYB	1	Exporter to the US	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 24, 2025	K250687	Cocoon Solo (DX-7020s)	MUH	Substantially Equivalent	Dexcowin Global, Inc.	accessdata.fda.gov
October 26, 2017	K173046	Cocoon Portable Handheld X-Ray System	MUH	Substantially Equivalent	Dexcowin Co., Ltd.	accessdata.fda.gov
October 5, 2015	K143494	ADX6000 Portable X-Ray System; iRayA6	IZL	Substantially Equivalent	Dexcowin Co., Ltd.	accessdata.fda.gov
May 13, 2014	K140060	DIGITAL DENTAL INTRA ORAL SENSOR, HDI 2000, HDI 2000A	MQB	Substantially Equivalent	Rayence Co., Ltd.	accessdata.fda.gov
May 9, 2014	K134055	ADX4000W	MUH	Substantially Equivalent	Dexcowin Co., Ltd.	accessdata.fda.gov
April 24, 2014	K133007	DX3000-L	MUH	Substantially Equivalent	Dexcowin Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated October 24, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.