FDA 510(k) Application Details - K022975

Device Classification Name	Material, Tooth Shade, Resin   More FDA Info for this Device
510(K) Number	K022975
Device Name	Material, Tooth Shade, Resin
Applicant	AB ARDENT 54 RIVERVIEW AVE. TONAWANDA, NY 14150-5260 US Other 510(k) Applications for this Company
Contact	CLYDE E INGERSOLL 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	09/06/2002
Decision Date	11/22/2002
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