FDA 510(k) Application Details - K111423

Device Classification Name	Laser,Fluorescence Caries Detection   More FDA Info for this Device
510(K) Number	K111423
Device Name	Laser,Fluorescence Caries Detection
Applicant	CARESTREAM HEALTH,INC. 1765 THE EXCHANGE ATLANTA, GA 30339 US Other 510(k) Applications for this Company
Contact	DANIEL HOEFER 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	05/23/2011
Decision Date	03/02/2012
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