FDA 510(k) Application Details - K053103

Device Classification Name	Agent, Tooth Bonding, Resin   More FDA Info for this Device
510(K) Number	K053103
Device Name	Agent, Tooth Bonding, Resin
Applicant	APEX DENTAL MATERIALS, INC. 23329 MALLARD COURT DEER PARK, IL 60010 US Other 510(k) Applications for this Company
Contact	CHRIS KULTON 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	11/04/2005
Decision Date	02/01/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review