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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K253036
Device Name Light-curing Coloring Materials (ALCM)
Applicant
Aidite (Qinhuangdao) Technology Co., Ltd.
#9 Dushan Rd., Economic & Technological Development Zone
Qinhuangdao,  CN 066004
Applicant Contact Hang Yang
Correspondent
Shanghai Truthful Information Technology Co., Ltd.
Rm. 1801, # 161 E. Lu Jiazui Rd., Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number872.3690
Classification Product Code
EBF  
Date Received09/22/2025
Decision Date 04/06/2026
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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