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510(k) K250687

Cocoon Solo (DX-7020s) by Dexcowin Global, Inc. — Product Code MUH

K250687 is an FDA 510(k) premarket notification submitted by Dexcowin Global, Inc. for the device "Cocoon Solo (DX-7020s)". The FDA issued a decision of Substantially Equivalent on October 24, 2025. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 2025
Date Received
March 6, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Extraoral Source, Digital
Device Class
Class II
Regulation Number
872.1800
Review Panel
RA
Submission Type

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FDA data resources