FDA 510(k) Application Details - K002322

Device Classification Name	Cement, Dental   More FDA Info for this Device
510(K) Number	K002322
Device Name	Cement, Dental
Applicant	KURARAY AMERICA, INC. 200 PARK AVE. NEW YORK, NY 10166-3098 US Other 510(k) Applications for this Company
Contact	KOICHI KIKUCHI Other 510(k) Applications for this Contact
Regulation Number	872.3275   More FDA Info for this Regulation Number
Classification Product Code	EMA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/31/2000
Decision Date	09/18/2000
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