FDA 510(k) Application Details - K043177

Device Classification Name	Material, Tooth Shade, Resin   More FDA Info for this Device
510(K) Number	K043177
Device Name	Material, Tooth Shade, Resin
Applicant	KURARAY MEDICAL INC. 101 EAST 52ND STREET, 26TH FL. NEW YORK, NY 10022 US Other 510(k) Applications for this Company
Contact	SATOSHI YAMAGUCHI Other 510(k) Applications for this Contact
Regulation Number	872.3690   More FDA Info for this Regulation Number
Classification Product Code	EBF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/16/2004
Decision Date	12/17/2004
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