FDA 510(k) Application Details - K073483

Device Classification Name	More FDA Info for this Device
510(K) Number	K073483
Device Name	SAPPHIRE O/E ORAL EXAMINATION SYSTEM
Applicant	DEN-MAT HOLDINGS, LLC 2727 SKYWAY DR. SANTA MARIA, CA 93455 US Other 510(k) Applications for this Company
Contact	ALAN MATTHEWS Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	NXV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/11/2007
Decision Date	04/03/2008
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