K251206
- 510(k) number
- K251206
- Device name
- Digital X-Ray DentiMax Pro Imaging System
- Applicant
- Dentimax, Inc. AZ · US
- Product code
- MUH — System, X-Ray, Extraoral Source, Digital
- Decision date
- 2025-09-24
- Date received
- 2025-04-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K251206.pdf
Official FDA record: K251206
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.