FDA 510(k) Application Details - K062382

Device Classification Name	Agent, Tooth Bonding, Resin   More FDA Info for this Device
510(K) Number	K062382
Device Name	Agent, Tooth Bonding, Resin
Applicant	KURARAY MEDICAL INC. 600 LEXINGTON AVENUE 26TH FLOOR NEW YORK, NY 10022 US Other 510(k) Applications for this Company
Contact	KOJI NISHIDA 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	08/15/2006
Decision Date	09/27/2006
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