FDA 510(k) Application Details - K061481

Device Classification Name	Adhesive, Bracket And Tooth Conditioner, Resin   More FDA Info for this Device
510(K) Number	K061481
Device Name	Adhesive, Bracket And Tooth Conditioner, Resin
Applicant	ORMCO CORP. 100 BAYVIEW CIRCLE SUITE 6000 NEWPORT BEACH, CA 92660 US Other 510(k) Applications for this Company
Contact	COLLEEN BOSWELL Other 510(k) Applications for this Contact
Regulation Number	872.3750   More FDA Info for this Regulation Number
Classification Product Code	DYH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/30/2006
Decision Date	07/06/2006
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