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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Extraoral Source, Digital
510(k) Number K250687
Device Name Cocoon Solo (DX-7020s)
Applicant
Dexcowin Global, Inc.
Office # 878 Regus Center 155 Lake Ave., Suite 800
Pasadena,  CA  91101
Applicant Contact Seung-Bum Ryu
Correspondent
Mtech Group, LLC
7505 Fannin St. Suite 610
Houston,  TX  77054
Correspondent Contact Dave Kim
Regulation Number872.1800
Classification Product Code
MUH  
Date Received03/06/2025
Decision Date 10/24/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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