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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 K250497
Device Name Additive Manufacturing (Light Curing) Crown Bridge Resin
Applicant
Aidite (Qinhuangdao) Technology Co., Ltd.
#9 Dushan Rd.,
Economic And Technological Development Zone
Qinhuangdao,  CN 066004
Applicant Contact Zhanfu Ye
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  
Subsequent Product Codes
EBG   POW   PZY  
Date Received02/20/2025
Decision Date 04/30/2025
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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