FDA 510(k) Application Details - K111696

Device Classification Name	Adhesive, Bracket And Tooth Conditioner, Resin   More FDA Info for this Device
510(K) Number	K111696
Device Name	Adhesive, Bracket And Tooth Conditioner, Resin
Applicant	ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH SOUTH JORDAN, UT 84095 US Other 510(k) Applications for this Company
Contact	DIANE ROGERS 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	06/17/2011
Decision Date	09/07/2011
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