FDA 510(k) Application Details - K092616

Device Classification Name	Agent, Tooth Bonding, Resin   More FDA Info for this Device
510(K) Number	K092616
Device Name	Agent, Tooth Bonding, Resin
Applicant	CAO GROUP, INC. 4628 WEST SKYHAWK DRIVE WEST JORDAN, UT 84084 US Other 510(k) Applications for this Company
Contact	ROBERT K LARSEN 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	08/26/2009
Decision Date	10/21/2009
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