FDA 510(k) Application Details - K112186

Device Classification Name	Crown And Bridge, Temporary, Resin   More FDA Info for this Device
510(K) Number	K112186
Device Name	Crown And Bridge, Temporary, Resin
Applicant	BIOLOREN SRL VIA ALESSANDRO VOLTA 59 SARONNO -- IT Other 510(k) Applications for this Company
Contact	ANDREA RATTI Other 510(k) Applications for this Contact
Regulation Number	872.3770   More FDA Info for this Regulation Number
Classification Product Code	EBG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/29/2011
Decision Date	11/08/2011
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