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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 K214005
Device Name Zirconia Dental Ceramics
Applicant
Shenzhen Yurucheng Dental Materials Co., Ltd.
101-201, Bldg. 4, #1 Branch Of Zhongcheng Life Science
Park, # 14 Zhongxing Rd.
Shenzhen,  CN 518000
Applicant Contact Fiya Liao
Correspondent
Shenzhen Joyantech Consulting Co., Ltd.
1713a, 17th Floor, Block A
Zhongguan Times Square Nanshan District
Shenzhen,  CN 518000
Correspondent Contact Grace Liu
Regulation Number872.6660
Classification Product Code
EIH  
Date Received12/21/2021
Decision Date 02/18/2022
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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