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510(k) Data Aggregation

    K Number
    K223816
    Device Name
    Dental CT Scanner AXR
    Date Cleared
    2023-04-07

    (108 days)

    Product Code
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    Alliage S/A Industrias Medico Odontológica

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The DENTAL CT SCANNER AXR is designed to obtain 2D and 3D radiological images of the oral anatomy, including teeth, maxillofacial areas, oral structures, carpal images and head-neck bone regions. This system is exclusively for dental use and should be handled only by qualified health professionals.
    Device Description
    The Dental CT Scanner AXR is a complete 4-in-1 dental imaging system capable of generating panoramic, cephalometric and tomographic images using cone beam computerized tomography technique (Cone Beam). The AXR90 has a maximum kVp of 90 while the AXR120 has a maximum kVp of 120. The digital acquisition process utilizes an X-ray sensor and automatic image processing that allow you to increase the speed of diagnosis and improve the workflow of your clinic.
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    K Number
    K210820
    Device Name
    EAGLE EDGE AXR90 and AXR120
    Date Cleared
    2021-08-10

    (144 days)

    Product Code
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    Alliage S/A Industrias Medico Odontológica

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The EAGLE EDGE AXR90 and AXR120 are CBCT / Panoramic / Cephalometric X-Ray units designed to obtain 2D and 3D radiological images of the oral anatomy, including teeth, maxillofacial areas, oral structures, carpal images and head-neck bone regions. This system is exclusively for dental use and should be handled only by qualified health professionals.
    Device Description
    EAGLE EDGE Models AXR90, AXR120 are complete 3-in-1 dental imaging systems capable of generating panoramic, cephalometric and tomographic images using cone beam computerized tomography (CBCT) technique. The AXR90 has a maximum kVp of 90 while the AXR120 has a maximum kVp of 120. The digital acquisition process utilizes one or more X-ray sensors and automatic image processing that allow you to increase the speed of diagnosis and improve the workflow of your clinic.
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