FDA 510(k) Application Details - K181167

Device Classification Name	Powder, Porcelain   More FDA Info for this Device
510(K) Number	K181167
Device Name	Powder, Porcelain
Applicant	Liaoning Upcera Co., Ltd No.122 Xianghuai Road, Economic Development Zone Benxi 117004 CN Other 510(k) Applications for this Company
Contact	Charles Shen 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	05/02/2018
Decision Date	09/02/2018
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