BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇸🇪 Sweden

    LUXATOR LX HANDPIECE

    K Number: K133178 · Decision Nov 24, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    72
    Applicant Total
    1
    Review Days
    768

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    Basic Information

    Device Name
    LUXATOR LX HANDPIECE
    K Number
    K133178
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Directa AB
    Date Received
    October 17, 2013
    Decision Date
    November 24, 2015
    Product Code
    EGS
    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
    EGS Handpiece, Contra- And Right-Angle Attachment, Dental

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