BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇭 Switzerland

    JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST

    K Number: K250969 · Decision Jun 27, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    147
    Registration Numbers
    147
    Same Product Code
    399
    Applicant Total
    4
    Review Days
    88

    Basic Information

    Device Name
    JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST
    K Number
    K250969
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    872.3660
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dent4You AG
    Date Received
    March 31, 2025
    Decision Date
    June 27, 2025
    Product Code
    ELW
    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
    ELW Material, Impression

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