FDA 510(k) Application Details - K965091

Device Classification Name	Sealant, Pit And Fissure, And Conditioner   More FDA Info for this Device
510(K) Number	K965091
Device Name	Sealant, Pit And Fissure, And Conditioner
Applicant	KURARAY COMPANY, LTD. 200 PARK AVE. NEW YORK, NY 10166-3098 US Other 510(k) Applications for this Company
Contact	KOJI FUJITA 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	12/19/1996
Decision Date	03/27/1997
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