FDA 510(k) Application Details - K152861

Device Classification Name	Material, Impression   More FDA Info for this Device
510(K) Number	K152861
Device Name	Material, Impression
Applicant	DENTPLY INTERNATIONAL INC. 221 WEST PHILADELPHIA STREET, SUITE 60 YORK, PA 17405 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	09/30/2015
Decision Date	03/04/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review