BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Advanced Dental Appliance

    K Number: K203462 · Decision Feb 19, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    105
    Registration Numbers
    105
    Same Product Code
    212
    Applicant Total
    2
    Review Days
    87

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    Basic Information

    Device Name
    Advanced Dental Appliance
    K Number
    K203462
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    872.5570
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dasoft Partners
    Date Received
    November 24, 2020
    Decision Date
    February 19, 2021
    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 Dasoft Partners

    K Number Device Name
    K172991 Advanced Dental Applicance