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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name X-Ray, Tomography, Computed, Dental
510(k) Number K250839
Device Name Dental X-ray System
Applicant
Changzhou Boen Zhongding Medical Technology Co., Ltd.
1st To 2nd Floor, S. W. Side Of Bldg. B1, #9
Changyang Rd., W. Taihu Science And Technology Industrial
Changzhou,  CN 213100
Applicant Contact Shuo Huang
Correspondent
Changzhou Boen Zhongding Medical Technology Co., Ltd.
1st To 2nd Floor, S. W. Side Of Bldg. B1, #9
Changyang Rd., W. Taihu Science And Technology Industrial
Changzhou,  CN 213100
Correspondent Contact Shuo Huang
Regulation Number892.1750
Classification Product Code
OAS  
Subsequent Product Code
EHD  
Date Received03/20/2025
Decision Date 06/11/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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