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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 K253131
Device Name Curing Light (M-Cure 6)
Applicant
Guangzhou Rebornendo Medical Instrument Co., Ltd.
Rm. 309, Bldg. #5, #2, Xingye Rd., Nansha District
Guangzhou,  CN 511478
Applicant Contact Cuimei Ye
Correspondent
Qimmiq Medical Consulting Service Co., Ltd.
Rm.406, Bldg. C, Run Science Park, #18 Shenzhou Rd.
Huangpu
Guangzhou,  CN 510663
Correspondent Contact Yijie You
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received09/25/2025
Decision Date 06/18/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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