BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    The Panthera Anti-Snoring X3 Device

    K Number: K171576 · Decision Feb 22, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    105
    Registration Numbers
    105
    Same Product Code
    212
    Applicant Total
    6
    Review Days
    268

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    Basic Information

    Device Name
    The Panthera Anti-Snoring X3 Device
    K Number
    K171576
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    872.5570
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Panthera Dental, Inc.
    Date Received
    May 30, 2017
    Decision Date
    February 22, 2018
    Product Code
    LRK
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LRK Device, Anti-Snoring

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    Other Clearances by Panthera Dental, Inc.

    K Number Device Name
    K203596 Panthera Occlusal Appliance
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    K173466 Panthera Dental Milled Bars
    K143244 The Panthera Anti-Snoring Device