Dental X-ray System— 510(k) K250839

Substantially Equivalent

Changzhou 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.

Clearance details

Applicant
Changzhou Boen Zhongding Medical Technology Co., Ltd.
Product code
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
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