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510(k) Data Aggregation

    K Number
    K172918
    Device Name
    DEXIS Titanium, KaVo IXS HD (Size 1, Size 2)
    Manufacturer
    KaVo Dental Technologies, LLC
    Date Cleared
    2017-12-18

    (84 days)

    Product Code
    MUH
    Regulation Number
    872.1800
    Why did this record match?
    Applicant Name (Manufacturer) :

    KaVo Dental Technologies, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DEXIS / KaVo sensor is a USB-driven digital sensor which is intended to acquire dental intraoral radiographic images. The DEXIS / KaVo sensor shall be operated by healthcare professionals, who are educated and competent to perform the acquisition of dental intra-oral radiographs. The DEXIS / KaVo sensor can be used either in combination with special positioning devices to facilitate positioning and alignment with the x-ray beam or it may also be positioned by hand with the assistance of the patient.
    Device Description
    The DEXIS Titanium, Kavo IXS HD (Size 1, Size 2) intraoral sensors are an indirect converting x-ray detector, e.g. incident x-rays are converted by a scintillating material into (visible) light, this light is coupled optically to a light detection imager based on CMOS technology. The design of the sensor assembly supports the automatic detection of the incident x-rays to generate digital images for dental intra oral applications. The DEXIS Titanium, Kavo IXS HD (Size 1, Size 2) intraoral sensors supports USB2.0 connectivity to personal computers using a dedicated electronic assembly and a sensor software driver.
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