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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Activator, Ultraviolet, For Polymerization
510(k) Number K220826
Device Name LED Curing Light
Applicant
Foshan Coxo Medical Instrument Co., Ltd.
Bldg. 4, District A, Guangdong New Light Source
Industrial Base, S. Of Luocun Ave.
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 Number872.6070
Classification Product Code
EBZ  
Date Received03/22/2022
Decision Date 12/08/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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