FDA 510(k) Application Details - K061611

Device Classification Name	Agent, Tooth Bonding, Resin   More FDA Info for this Device
510(K) Number	K061611
Device Name	Agent, Tooth Bonding, Resin
Applicant	HARRY J. BOSWORTH CO. 7227 NORTH HAMLIN AVE. SKOKIE, IL 60076 US Other 510(k) Applications for this Company
Contact	MILDRED M GOLDSTEIN 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	06/09/2006
Decision Date	09/11/2006
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