FDA 510(k) Application Details - K011517

Device Classification Name	Material, Tooth Shade, Resin   More FDA Info for this Device
510(K) Number	K011517
Device Name	Material, Tooth Shade, Resin
Applicant	FIRST SCIENTIFIC LIMITED 7 ROSEHEYWORTH BUSINESS PARK ABERTILLERY BLAENAU GWENT, WALES NP13 1SP GB Other 510(k) Applications for this Company
Contact	ADE AKINMADE 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	05/17/2001
Decision Date	07/10/2001
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