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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Extraoral Source, Digital
510(k) Number K231660
Device Name Digital image scanner of dental
Applicant
Jiangsu Dynamic Medical Technology Co., Ltd.
# 108 Xingpu Rd., Lujia Town, Kunshan
Suzhou,  CN 215331
Applicant Contact Xiang Long Liu
Correspondent
Shanghai CV Technology Co., Ltd.
Rm. 602, #19 Dongbao Rd., Songjiang Area,
Shanghai,  CN 201613
Correspondent Contact Doris Dong
Regulation Number872.1800
Classification Product Code
MUH  
Date Received06/07/2023
Decision Date 12/20/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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