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FDA 510(k) Application Details - K230003
Device Classification Name
Powder, Porcelain
More FDA Info for this Device
510(K) Number
K230003
Device Name
Powder, Porcelain
Applicant
Topzir Biotech Co., Ltd
Room 203, Creative Center, No.69, Guangpu West Road,
Huangpu District
Guangzhou 510663 CN
Other 510(k) Applications for this Company
Contact
Hui Liu
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
01/03/2023
Decision Date
03/31/2023
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
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