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510(k) Data Aggregation

    K Number
    K112139
    Device Name
    THE CANARY SYSTEM
    Date Cleared
    2012-10-26

    (458 days)

    Product Code
    Regulation Number
    872.1745
    Why did this record match?
    Applicant Name (Manufacturer) :

    QUANTUM DENTAL TECHNOLOGIES INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Canary System is intended to be used by qualified dental professionals as an aid in the detection and monitoring of dental canes, and as an intra-oral camera to record anatomical details. The Canary System is indicated as an aid in the detection and monitoring of dental caries and as an intraoral camera to visualize and record anatomical details. 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.
    Device Description
    The Canary System™ uses a low powered 660 nm wavelength laser to examine the tooth surface. When this laser light is shone on the tooth the laser light is scattered and absorbed. An absorbed portion of the light is converted into heat and emits thermal infrared (Photothermal Radiometry, PTR) and another part of the light excites the tissue and emits optically converted light (Luminescence; LUM), which shows the difference between what appears to be healthy tooth structure and areas suspected of being carious tooth structure. Compared to a healthy tooth, areas suspected of being canous or possibly having other defects such as micro cracks absorb more light and generate higher PTR signals and lower LUM signals. The Canary System is very safe because the temperature rise on the tooth surface by the laser is only 1 - 2℃, which is much lower temperature than hot beverages. Modulated laser light hitting the tooth surface generates a thermal diffusion (heat transfer) wave. The depth that this wave can penetrate is determined by the modulation frequency. Even though its sensitivity is lower than PTR, modulated light scattering also gives information from deep inside the enamel by luminescence. The Canary System can detect suspect areas, up to a depth of 5mm because The Canary System uses a 2Hz frequency modulation that penetrates deeper than higher frequencies (100s or 1000s Hz) and the detected PTR/LUM signals deliver integrated information from the surface to the penetration depth. The measured PTR and LUM signals are combined into a Canary Number. As the suspicion of a carious lesion develops, the Canary Number increases. With remineralization treatment, or lesion reduction in size, the Canary Number appears to decrease. The Canary System is associated with a photographic image of the tooth surface being examined. The images are displayed on an accompanying monitor for immediate chair-side review with the patient. Images are also shown in Canary Reports incorporating Canary Numbers and color codes for the examined teeth. The Canary software is able to record and store the Canary Numbers, images of the surfaces examined, along with the dentist's treatment recommendation.
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