FDA 510(k) Application Details - K974089

Device Classification Name	Agent, Tooth Bonding, Resin   More FDA Info for this Device
510(K) Number	K974089
Device Name	Agent, Tooth Bonding, Resin
Applicant	KURARAY AMERICA, INC. 200 PARK AVE. NEW YORK, NY 10166-3098 US Other 510(k) Applications for this Company
Contact	KEJI FUJITA Other 510(k) Applications for this Contact
Regulation Number	872.3200   More FDA Info for this Regulation Number
Classification Product Code	KLE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/29/1997
Decision Date	12/17/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review