The Canary System

FDA 510(k) K112139 · Quantum Dental Technologies, Inc.

Substantially Equivalent

510(k) numberK112139

Submission

Device name
The Canary System
Applicant
Quantum Dental Technologies, Inc.
Toronto, CA
Received
July 26, 2011
Decision date
October 26, 2012
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NBL – Light-Induced Fluorescence Caries Detector
Device class
Class II (moderate risk)
Regulation
21 CFR 872.1745
Specialty
Dental

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K183471IC-WHCD100 (Inspire)NBL · Traditional Good Doctors Co., Ltd.07/02/2020SE
K171007Fluorescence ModeNBL · Traditional Carl Zeiss Suzhou Co., Ltd.05/03/2018SE
K170822Electronic Caries DetectorNBL · Traditional Ortek Therapeutics, Inc.09/11/2017SE
K150672VistaCam iX ProofNBL · Traditional Durr Dental AG01/27/2016SE

Questions and answers

When was The Canary System cleared by the FDA?

The Canary System (K112139) received a 510(k) decision of Substantially Equivalent on October 26, 2012, 458 days after the submission was received.

What is the product code of K112139?

The FDA product code is NBL – Light-Induced Fluorescence Caries Detector , a Class II (moderate risk) device regulated under 21 CFR 872.1745.