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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Scaler, Ultrasonic
510(k) Number K222096
Device Name Endo Ultrasonic Activator
Applicant
Foshan Coxo Medical Instrument Co., Ltd.
Bldg. 4,District A Guangdong New Light Source Industrial
Base,South Of Luocun,Ave. Nanhai
Foshan,  CN 528226
Applicant Contact Yongjian Zheng
Correspondent
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Bldg. #15, Xiyuehui
#5, Yihe N. Rd., Fangshan District
Beijing,  CN 102401
Correspondent Contact Ray Wang
Regulation Number872.4850
Classification Product Code
ELC  
Date Received07/18/2022
Decision Date 03/23/2023
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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