FDA 510(k) Application Details - K091635

Device Classification Name	Sealant, Pit And Fissure, And Conditioner   More FDA Info for this Device
510(K) Number	K091635
Device Name	Sealant, Pit And Fissure, And Conditioner
Applicant	HERAEUS KULZER, LLC 300 HERAEUS WAY SOUTH BEND, IN 46614 US Other 510(k) Applications for this Company
Contact	CHERYL ZIMMERMAN Other 510(k) Applications for this Contact
Regulation Number	872.3765   More FDA Info for this Regulation Number
Classification Product Code	EBC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/04/2009
Decision Date	09/03/2009
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