FDA 510(k) Application Details - K112152

Device Classification Name	Powder, Porcelain   More FDA Info for this Device
510(K) Number	K112152
Device Name	Powder, Porcelain
Applicant	DENTSPLY INTERNATIONAL, INC. SUSQUEHANNA COMMERCE CTR., 221 W. PHILADELPHIA ST., SUITE 60 YORK, PA 17404 US Other 510(k) Applications for this Company
Contact	HELEN LEWIS 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	07/27/2011
Decision Date	11/09/2011
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