FDA 510(k) Application Details - K063321

Device Classification Name	Laser,Fluorescence Caries Detection   More FDA Info for this Device
510(K) Number	K063321
Device Name	Laser,Fluorescence Caries Detection
Applicant	NEKS TECHNOLOGIES, INC. 2816, JOSEPH A. BOMBARDIER LAVAL, QUEBEC H7P 6E2 CA Other 510(k) Applications for this Company
Contact	NAIM KARAZIVAN Other 510(k) Applications for this Contact
Regulation Number	872.1745   More FDA Info for this Regulation Number
Classification Product Code	NBL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/02/2006
Decision Date	03/30/2007
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