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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 K223742
Device Name Dental Ceramic Blocks
Applicant
Aidite (Qinhuangdao) Technology Co., Ltd.
# 9 Dushan Rd., Economic And Technological
Development Zone
Qinhuangdao,  CN 066000
Applicant Contact Chen Yingying
Correspondent
Icas Group
155 Pingbei Rd., Minghang
Shanghai,  CN 201100
Correspondent Contact Julie Chen
Regulation Number872.3690
Classification Product Code
EBF  
Date Received12/14/2022
Decision Date 03/08/2023
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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