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

    VELMENI for DENTISTS (V4D)

    K Number: K250753 · Decision Sep 2, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    36
    Applicant Total
    3
    Review Days
    174

    Basic Information

    Device Name
    VELMENI for DENTISTS (V4D)
    K Number
    K250753
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2070
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Velmeni, Inc.
    Date Received
    March 12, 2025
    Decision Date
    September 2, 2025
    Product Code
    MYN
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MYN Analyzer, Medical Image

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    Other Clearances by Velmeni, Inc.

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    K252953 Velmeni for Dentists (V4D) Endo-Perio
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