FDA 510(k) Application Details - K980054

Device Classification Name	Material, Tooth Shade, Resin   More FDA Info for this Device
510(K) Number	K980054
Device Name	Material, Tooth Shade, Resin
Applicant	TOKUYAMA AMERICA, INC. 1233 20TH., N.W. #700 WASHINGTON, DC 20036 US Other 510(k) Applications for this Company
Contact	DANIEL J MANELLI 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	01/06/1998
Decision Date	04/27/1998
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