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