FDA 510(k) Application Details - K102128

Device Classification Name	Powder, Porcelain   More FDA Info for this Device
510(K) Number	K102128
Device Name	Powder, Porcelain
Applicant	VITA ZAHNFABRIK H. RAUTER GMBH & CO. 3150 EAST BIRCH STREET BREA, CA 92821 US Other 510(k) Applications for this Company
Contact	ELIZABETH WOLFSEN 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	07/29/2010
Decision Date	08/11/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	Y
Expedited Review