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510(k) Data Aggregation

    K Number
    K232293
    Device Name
    kallisio stentra™ oral stent
    Manufacturer
    Kallisio, Inc
    Date Cleared
    2023-12-22

    (143 days)

    Product Code
    IYE
    Regulation Number
    892.5050
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    Applicant Name (Manufacturer) :

    Kallisio, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The kallisio Stentra™ oral stent is intended to be used for repeat positioning and immobilization of a patient's tongue and jaw while undergoing a course of external beam radiation therapy for treatment of cancer and other diseases. The kallisio Stentra oral stent is intended to be used by or under the direction of a licensed physician.
    Device Description
    The Kallisio Stentra Oral Stent is a single patient, reusable custom tongue and jaw positioner used for repeat positioning and immobilization of a patient's tongue and jaw while receiving a course of external beam radiation therapy for treatment of cancer and other diseases. Q-bite bite block accessories are supplied separately. The Stentra Stent is a prescription device.
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