Dental X-ray System— 510(k) K250839
Substantially EquivalentChangzhou Boen Zhongding Medical Technology Co., Ltd.
FDA 510(k) clearance K250839 for Dental X-ray System, Substantially Equivalent on 2026-06-11. Applicant: Changzhou Boen Zhongding Medical Technology Co., Ltd.. Device class: 2.
Summary
Changzhou Boen Zhongding Medical Technology's Dental X-ray System is filed under OAS, dental computed tomography x-ray systems. The name is generic, and the record gives no model numbers.
Class II, 21 CFR 892.1750. Radiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Boen Zhongding filed from Changzhou, China. Review took 448 calendar days (March 20, 2025 to June 11, 2026).
Clearance details
- Applicant
- Changzhou Boen Zhongding Medical Technology Co., Ltd.
- Product code
- Product code OAS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1750
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Changzhou, CN
Recent devices under product code OAS
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