FDA 510(k) Application Details - K090598

Device Classification Name	Laser,Fluorescence Caries Detection   More FDA Info for this Device
510(K) Number	K090598
Device Name	Laser,Fluorescence Caries Detection
Applicant	CARIESCAN LTD. PROSPECT BUSINESS CENTRE THE TECHNOLOGY PARK DUNDEE DD2 1SW GB Other 510(k) Applications for this Company
Contact	NIKOLA SKELLY 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	03/05/2009
Decision Date	12/15/2009
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