FDA 510(k) Application Details - K151047

Device Classification Name	Resin, Root Canal Filling   More FDA Info for this Device
510(K) Number	K151047
Device Name	Resin, Root Canal Filling
Applicant	ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS RUA WALDIR LANDGRAF, 101 LONDRINA, PR 86031-218 BR Other 510(k) Applications for this Company
Contact	Paulo Sergio Calixto de Oliveria Other 510(k) Applications for this Contact
Regulation Number	872.3820   More FDA Info for this Regulation Number
Classification Product Code	KIF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/20/2015
Decision Date	08/31/2016
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