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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Direct Drive, Ac-Powered
510(k) Number K192649
Device Name Endo Motor
Applicant
Foshan Cicada Dental Instrument Co, Ltd.
B5-2f, Guangdong New Light Source Industrial Base
Shihan Town,
Nanhai District, Foshan,  CN
Applicant Contact Juan Liu
Correspondent
Guangzhou Keda Biological Tech Co., Ltd.
6f, #1 Tiantai Rd., Science City, Luogang District
Gaungzhou,  CN
Correspondent Contact Jet Li
Regulation Number872.4200
Classification Product Code
EKX  
Date Received09/24/2019
Decision Date 03/12/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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