FDA 510(k) Application Details - K090106

Device Classification Name	Agent, Tooth Bonding, Resin   More FDA Info for this Device
510(K) Number	K090106
Device Name	Agent, Tooth Bonding, Resin
Applicant	DANVILLE MATERIALS, INC. 3420 FOSTORIA WAY, SUITE A-200 SAN RAMON, CA 94583 US Other 510(k) Applications for this Company
Contact	LINDSAY TILTON Other 510(k) Applications for this Contact
Regulation Number	872.3200   More FDA Info for this Regulation Number
Classification Product Code	KLE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/01/2009
Decision Date	03/31/2009
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