FDA 510(k) Application Details - K011239

Device Classification Name	Coating, Filling Material, Resin   More FDA Info for this Device
510(K) Number	K011239
Device Name	Coating, Filling Material, Resin
Applicant	COSMEDENT, INC. 401 N. MICHIGAN AVE. SUITE 2500 CHICAGO, IL 60611 US Other 510(k) Applications for this Company
Contact	MICHAEL O'MALLEY Other 510(k) Applications for this Contact
Regulation Number	872.3310   More FDA Info for this Regulation Number
Classification Product Code	EBD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/23/2001
Decision Date	02/14/2002
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