FDA 510(k) Application Details - K112139

Device Classification Name	Laser,Fluorescence Caries Detection   More FDA Info for this Device
510(K) Number	K112139
Device Name	Laser,Fluorescence Caries Detection
Applicant	QUANTUM DENTAL TECHNOLOGIES INC 748 BRIAR HILL AVENUE TORONTO, ONTARIO M6B 1L3 CA Other 510(k) Applications for this Company
Contact	JOSH SILVERTOWN 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	07/26/2011
Decision Date	10/26/2012
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