BEUDAMED
    Product Code: QUA FDA class 2 21 CFR 872.5590

    Intraoral Cooling Device

    Dental

    The Intraoral Cooling Device is a prescription device consisting of a removable mouthpiece and accessories designed to cool the oral mucosal surfaces of patients at risk for oral mucositis, a painful side effect of cancer chemotherapy that affects the mouth and throat lining. By cooling the oral tissues, the device aims to reduce blood flow and drug delivery to these tissues during chemotherapy administration. Classified as FDA Class 2 under regulation 872.5590, it requires 510(k) clearance in the Dental specialty. It is not an implant and not life-sustaining.

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    510(k)s
    2
    FEI Numbers
    4
    Registration Numbers
    4
    Unique Applicants
    2
    Years Active
    1

    Basic Information

    Product Code
    QUA
    Device Class
    FDA class 2
    Regulation Number
    872.5590
    Medical Specialty
    Dental
    Review Panel
    DE
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    An intraoral cooling device is a prescription use device that is intended to cool the mouth for patients at risk for oral mucositis. An intraoral cooling device consists of a removable mouthpiece and accessories that cool oral mucosal surfaces

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 2 510(k) clearances via K numbers.

    K Number Device Name
    K232917 Chemo Mouthpiece
    DEN210027 The Cooral System

    FEI Numbers

    This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.