FDA 510(k) Application Details - K973513

Device Classification Name	Material, Tooth Shade, Resin   More FDA Info for this Device
510(K) Number	K973513
Device Name	Material, Tooth Shade, Resin
Applicant	ESPE GMBH & CO. KG. AM GRIESBERG 2 SEEFELD D-82229 DE Other 510(k) Applications for this Company
Contact	BARBARA WAGNER-SCHUH 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	09/17/1997
Decision Date	12/22/1997
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