FDA 510(k) Application Details - K121735

Device Classification Name	Material, Tooth Shade, Resin   More FDA Info for this Device
510(K) Number	K121735
Device Name	Material, Tooth Shade, Resin
Applicant	BIOLOREN SRL VIA ALESSANDRO VOLTA 59 SARONNO, VA 21047 IT Other 510(k) Applications for this Company
Contact	RATTI ANDREA 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	06/13/2012
Decision Date	02/21/2013
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