FDA 510(k) Application Details - K132984

Device Classification Name	Denture, Plastic, Teeth   More FDA Info for this Device
510(K) Number	K132984
Device Name	Denture, Plastic, Teeth
Applicant	IVOCLAR VIVADENT, INC. 175 PINEVIEW DR. AMHERST, NY 14228 US Other 510(k) Applications for this Company
Contact	DONNA MARIE HARTNETT Other 510(k) Applications for this Contact
Regulation Number	872.3590   More FDA Info for this Regulation Number
Classification Product Code	ELM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/24/2013
Decision Date	01/14/2014
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