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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Teeth, Porcelain
510(k) Number K240586
Device Name Additive Manufacturing Zirconia Customized Restoration
Applicant
Hangzhou Thales Medtech Co., Ltd.
1001 Rm. 3# First Floor, 1building, 8 Block
Zhuantang Technological And Economic Zone, Xihu District
Hangzhou,  CN 310000
Applicant Contact Wang Shuo
Correspondent
Beijing Xinranyicheng Medicine & Technology Co., Ltd.
A-1109, Langqin International Bldg., #168,
Guang'Anmen Outer St., Xicheng District
Beijing,  CN 10053
Correspondent Contact Chen Kaimin
Regulation Number872.3920
Classification Product Code
ELL  
Subsequent Product Code
EIH  
Date Received03/01/2024
Decision Date 10/03/2024
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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