Identifiers
- 510(k) Number
- K112139 FDA 510(k)
- FDA Product Code
- NBL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.1745 FDA 510(k)
- Regulation Number
- 872.1745 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Canary System is a laser fluorescence caries detection device used for the early detection of dental caries and defects in tooth structure. It is substantially equivalent to predicate devices and classified under product code NBL with regulation number 872.1745.
The device is supplied as a reusable system and is intended for use in dental settings. It has received FDA 510(k) clearance (K112139) and is manufactured by Quantum Dental Technologies, Inc. No claims regarding sterility, single-use status, MRI safety, or storage conditions are present in the provided data.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Canary – ein vollständiges Sicherheitssystem in einem Gerät., The Canary System, Quantum Dental Technologies | The Canary System™, The Canary System from Quantum Dental Technologies
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K112139 | Class II | Active |
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Manufacturer
- Manufacturer
- Quantum Dental Technologies, Inc.
Sources (1)
- FDA 510(k) K112139 24 fields · synced Sep 22, 2026