K250839
- 510(k) number
- K250839
- Device name
- Dental X-ray System
- Applicant
- Changzhou Boen Zhongding Medical Technology Co., Ltd. CN
- Product code
- OAS — X-Ray, Tomography, Computed, Dental
- Decision date
- 2026-06-11
- Date received
- 2025-03-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K250839.pdf
Official FDA record: K250839
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.