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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 K233016
Device Name Dental Glass Ceramics
Applicant
Shenzhen Yurucheng Dental Materials Co., Ltd.
101-201, Building 4, No.1 Branch of Zhongcheng Life Science
Park, No. 14 Zhongxing Road, Xiuxin
Kengzi Street Office, Pingshan District,,  CN 518122
Applicant Contact Hongfei Liao
Correspondent
Guangzhou Junyi Information Technology Co., Ltd.
Room 304, Building A, No. 62 Nanyun 2nd Road, Science Town
Huangpu District, Guangzhou City,  CN 510663
Correspondent Contact Shanfeng Jiang
Regulation Number872.6660
Classification Product Code
EIH  
Date Received09/22/2023
Decision Date 12/21/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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