FDA 510(k) Application Details - K093560

Device Classification Name	Powder, Porcelain   More FDA Info for this Device
510(K) Number	K093560
Device Name	Powder, Porcelain
Applicant	SHENYANG UPCERA CO., LTD. 1705 S. CAPITAL OF TEXAS HWY SUITE 500 AUSTIN, TX 78746 US Other 510(k) Applications for this Company
Contact	STUART R GOLDMAN 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	11/18/2009
Decision Date	01/28/2010
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