FDA 510(k) Application Details - K992645

Device Classification Name	Material, Tooth Shade, Resin   More FDA Info for this Device
510(K) Number	K992645
Device Name	Material, Tooth Shade, Resin
Applicant	ESPE DENTAL AG ESPE PLATZ SEEFELD, BAVARIA D-82229 DE Other 510(k) Applications for this Company
Contact	ANDREAS PETERMANN 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	08/06/1999
Decision Date	09/22/1999
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