K250687
- 510(k) number
- K250687
- Device name
- Cocoon Solo (DX-7020s)
- Applicant
- Dexcowin Global, Inc. CA · US
- Product code
- MUH — System, X-Ray, Extraoral Source, Digital
- Decision date
- 2025-10-24
- Date received
- 2025-03-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K250687.pdf
Official FDA record: K250687
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.