FDA 510(k) Application Details - K073047

Device Classification Name	Material, Tooth Shade, Resin   More FDA Info for this Device
510(K) Number	K073047
Device Name	Material, Tooth Shade, Resin
Applicant	APROXI APS HOJELOFT VAENGE 206 VAERLOSE DK Other 510(k) Applications for this Company
Contact	KIRSTEN RONO 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	10/29/2007
Decision Date	08/07/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review