FDA 510(k) Application Details - K082668

Device Classification Name	More FDA Info for this Device
510(K) Number	K082668
Device Name	BIO-SCREEN
Applicant	ADDENT, INC. 43 MIRY BROOK RD. DANBURY, CT 06810 US Other 510(k) Applications for this Company
Contact	JOSHUA FRIEDMAN Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	NXV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/12/2008
Decision Date	01/23/2009
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