FDA 510(k) Application Details - K132923

Device Classification Name	Agent, Tooth Bonding, Resin   More FDA Info for this Device
510(K) Number	K132923
Device Name	Agent, Tooth Bonding, Resin
Applicant	ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS SA 18851 NE 29TH AVE 720 AVENTURA, FL 33180 US Other 510(k) Applications for this Company
Contact	TARA CONRAD Other 510(k) Applications for this Contact
Regulation Number	872.3200   More FDA Info for this Regulation Number
Classification Product Code	KLE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/18/2013
Decision Date	01/03/2014
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