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FDA 510(k) Application Details - K233016
Device Classification Name
Powder, Porcelain
More FDA Info for this Device
510(K) Number
K233016
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, Xiuxin
Kengzi Street Office, Pingshan District, 518122 CN
Other 510(k) Applications for this Company
Contact
Hongfei 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
09/22/2023
Decision Date
12/21/2023
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
FDA Source Information for K233016
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