FDA 510(k) Application Details - K121685

Device Classification Name	Laser,Fluorescence Caries Detection   More FDA Info for this Device
510(K) Number	K121685
Device Name	Laser,Fluorescence Caries Detection
Applicant	SOPRO 124 GAITHER DRIVE SUITE 140 MT. LAUREL, NJ 08054 US Other 510(k) Applications for this Company
Contact	RICK ROSATI 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	06/07/2012
Decision Date	03/12/2013
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