FDA 510(k) Application Details - K050401

Device Classification Name	Material, Tooth Shade, Resin   More FDA Info for this Device
510(K) Number	K050401
Device Name	Material, Tooth Shade, Resin
Applicant	SHOFU DENTAL CORP. 1225 STONE DR. SAN MARCOS, CA 92078 US Other 510(k) Applications for this Company
Contact	DAVID MORAIS 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	02/17/2005
Decision Date	04/28/2005
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