FDA 510(k) Application Details - K060365

Device Classification Name	Liner, Cavity, Calcium Hydroxide   More FDA Info for this Device
510(K) Number	K060365
Device Name	Liner, Cavity, Calcium Hydroxide
Applicant	IVOCLAR VIVADENT, INC. 175 PINEVIEW DR. AMHERST, NY 14228 US Other 510(k) Applications for this Company
Contact	DONNA M HARTNETT Other 510(k) Applications for this Contact
Regulation Number	872.3250   More FDA Info for this Regulation Number
Classification Product Code	EJK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/13/2006
Decision Date	04/17/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review