FDA 510(k) Application Details - K113406

Device Classification Name	Material, Impression   More FDA Info for this Device
510(K) Number	K113406
Device Name	Material, Impression
Applicant	DENTSPLY INTERNATIONAL, INC. 221 W. PHILADELPHIA ST., SE 60 SUSQUEHANNA COMMERCE CTR. YORK, PA 17404 US Other 510(k) Applications for this Company
Contact	HELEN LEWIS Other 510(k) Applications for this Contact
Regulation Number	872.3660   More FDA Info for this Regulation Number
Classification Product Code	ELW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/18/2011
Decision Date	02/13/2012
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