FDA 510(k) Application Details - K130991

Device Classification Name	Powder, Porcelain   More FDA Info for this Device
510(K) Number	K130991
Device Name	Powder, Porcelain
Applicant	SAGEMAX BIOCERAMICS, INC. 34210 9th Ave S Suite 118 Federal Way, WA 98003 US Other 510(k) Applications for this Company
Contact	JOSE E CABRERA 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	04/10/2013
Decision Date	02/10/2014
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