FDA 510(k) Application Details - K143575

Device Classification Name	Material, Impression   More FDA Info for this Device
510(K) Number	K143575
Device Name	Material, Impression
Applicant	IVOCLAR VIVADENT, INC. 175 PINEVIEW DRIVE AMHERST, NY 14228 US Other 510(k) Applications for this Company
Contact	Donna Marie Hartnett 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	12/17/2014
Decision Date	04/03/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review