FDA 510(k) Application Details - K143292

Device Classification Name	Liner, Cavity, Calcium Hydroxide   More FDA Info for this Device
510(K) Number	K143292
Device Name	Liner, Cavity, Calcium Hydroxide
Applicant	Bisco Inc 1100 West Irving Park Road Schaumburg, IL 60193 US Other 510(k) Applications for this Company
Contact	Michelle Schiltz-Taing 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	11/17/2014
Decision Date	08/04/2015
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