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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name controller, foot, handpiece and cord
510(k) Number K202075
Device Name Dental Electric Motor
Applicant
Foshan CICADA Dental Instrument Co, Ltd.
B5-2F, Guangdong New Light Source Industrial Base, Nanhai
District
Foshan,  CN 528226
Applicant Contact Juan Liu
Correspondent
Guangzhou KEDA Biological Technology Co., Ltd
6F, No.1 TianTai Road, Science City, LuoGang District
Guangzhou,  CN 510010
Correspondent Contact Jet Li
Regulation Number872.4200
Classification Product Code
EBW  
Date Received07/27/2020
Decision Date 03/11/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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