FDA 510(k) Application Details - K062695

Device Classification Name	Powder, Porcelain   More FDA Info for this Device
510(K) Number	K062695
Device Name	Powder, Porcelain
Applicant	SAGEMAX BIOCERAMICS, INC. 11061 NE 2ND STREET SUITE 168 BELLEVUE, WA 98004 US Other 510(k) Applications for this Company
Contact	LARRY DANG 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	09/11/2006
Decision Date	10/20/2006
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