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FDA 510(k) Application Details - K214005
Device Classification Name
Powder, Porcelain
More FDA Info for this Device
510(K) Number
K214005
Device Name
Powder, Porcelain
Applicant
Shenzhen Yurucheng Dental Materials Co., Ltd.
101-201, Building 4, No.1 Branch of Zhongcheng Life Science
Park, No. 14 Zhongxing Road
Shenzhen 518000 CN
Other 510(k) Applications for this Company
Contact
Fiya Liao
Other 510(k) Applications for this Contact
Regulation Number
872.6660
More FDA Info for this Regulation Number
Classification Product Code
EIH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/21/2021
Decision Date
02/18/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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