510(k) K112139

THE CANARY SYSTEM by Quantum Dental Technologies, Inc. — Product Code NBL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 2012
Date Received
July 26, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Fluorescence Caries Detection
Device Class
Class II
Regulation Number
872.1745
Review Panel
DE
Submission Type