FDA 510(k) Application Details - K081291

Device Classification Name	Adhesive, Bracket And Tooth Conditioner, Resin   More FDA Info for this Device
510(K) Number	K081291
Device Name	Adhesive, Bracket And Tooth Conditioner, Resin
Applicant	DENTSPLY INTERNTIONAL 221 W. PHILADELPHIA ST. STE.60 SUSQUEHANNA COMMERCE CRT. WEST YORK, PA 17405 US Other 510(k) Applications for this Company
Contact	HELEN LEWIS 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	05/07/2008
Decision Date	05/22/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review