# K112139: The Canary System

- Pathway: 510(k) (Traditional)
- Applicant: Quantum Dental Technologies, Inc.
- Decided: Oct 26, 2012 after 458 days
- Product code: NBL (Light-Induced Fluorescence Caries Detector )
- Device class: 2
- Regulation: 21 CFR 872.1745
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN990002 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN990002: Kavo Diagnodent, Kavo America (2000). Our reading of the summary gave K983658, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN990002, Kavo Diagnodent (Kavo America), granted Feb 22, 2000; older De Novo requests were first filed under a 510(k) number, so this links to the grant.

## Cited in the summary but kept off the family tree
- K092533: Force Fiber Blue Ultra High Molecular Weight Polyethylene Non Absorbable Sutures, Beere Precision Medical Instruments, Kmedic, Telef (2009). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The Canary System is intended to be used by qualified dental professionals as an aid in the diagnosis of dental caries, and as an intra-oral camera to visualize and record anatomical details.

Source page: https://510kreport.com/device/K112139
Methodology: https://510kreport.com/methodology