Cleared Traditional

THE CANARY SYSTEM (K112139) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K112139 · Quantum Dental Technologies, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2012
Decision
458d
Days
Class 2
Risk

K112139 is an FDA 510(k) clearance for the THE CANARY SYSTEM. Classified as Laser, Fluorescence Caries Detection (product code NBL), Class II - Special Controls.

Submitted by Quantum Dental Technologies, Inc. (Toronto, CA). The FDA issued a Cleared decision on October 26, 2012 after a review of 458 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.1745 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Quantum Dental Technologies, Inc. devices

Submission Details

510(k) Number K112139 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2011
Decision Date October 26, 2012
Days to Decision 458 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
331d slower than avg
Panel avg: 127d · This submission: 458d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NBL Laser, Fluorescence Caries Detection
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1745
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - NBL Laser, Fluorescence Caries Detection

All 23
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