FDA 510(k) Application Details - K011908

Device Classification Name	Sealant, Pit And Fissure, And Conditioner   More FDA Info for this Device
510(K) Number	K011908
Device Name	Sealant, Pit And Fissure, And Conditioner
Applicant	KERR DENTAL MATERIALS CENTER 1717 WEST COLLINS AVE. ORANGE, CA 92867 US Other 510(k) Applications for this Company
Contact	COLLEEN BOSWELL 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	06/19/2001
Decision Date	09/06/2001
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