FDA 510(k) Application Details - K043156

Device Classification Name	Laser,Fluorescence Caries Detection   More FDA Info for this Device
510(K) Number	K043156
Device Name	Laser,Fluorescence Caries Detection
Applicant	NEKS TECHNOLOGIES, INC. 208 BARRINGTON OVERLOOK DRIVE DURHAM, NC 27703 US Other 510(k) Applications for this Company
Contact	CHARLES H KYPER 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	11/15/2004
Decision Date	04/28/2005
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