FDA 510(k) Application Details - K123823

Device Classification Name	Material, Tooth Shade, Resin   More FDA Info for this Device
510(K) Number	K123823
Device Name	Material, Tooth Shade, Resin
Applicant	ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS 18851 NE 29TH AVE 720 AVENTURA, FL 33180 US Other 510(k) Applications for this Company
Contact	LILIAN LLULL Other 510(k) Applications for this Contact
Regulation Number	872.3690   More FDA Info for this Regulation Number
Classification Product Code	EBF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/12/2012
Decision Date	05/31/2013
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