FDA 510(k) Application Details - K111321

Device Classification Name	Laser,Fluorescence Caries Detection   More FDA Info for this Device
510(K) Number	K111321
Device Name	Laser,Fluorescence Caries Detection
Applicant	CARIESCAN LTD. UNIT 5 GATEWAY WEST, LUNA PLACE, TECHNOLOGY PARK DUNDEE, ANGUS DD2 1XZ 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	05/11/2011
Decision Date	05/17/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review