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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powder, Porcelain
510(k) Number K222626
Device Name Dental Zirconia Ceramic
Applicant
Aidite (Qinhuangdao) Technology Co., Ltd.
#9 Dushan Rd.,
Economic And Technological Development Zone
Qinhuangdao,  CN 066004
Applicant Contact Chen Yingying
Correspondent
Shenzhen Joyantech Consulting Co., Ltd.
1713a, 17th Floor, Block A, Zhongguan Times Sq.
Nanshan District
Shenzhen,  CN 518000
Correspondent Contact Grace Liu
Regulation Number872.6660
Classification Product Code
EIH  
Date Received08/31/2022
Decision Date 12/06/2022
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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