BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    ELECTROTORQUE TLC

    K Number: K103027 · Decision Aug 19, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    69
    Registration Numbers
    69
    Same Product Code
    60
    Applicant Total
    9
    Review Days
    310

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    Basic Information

    Device Name
    ELECTROTORQUE TLC
    K Number
    K103027
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kaltenbach & Voigt GmbH
    Date Received
    October 13, 2010
    Decision Date
    August 19, 2011
    Product Code
    EBW
    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
    EBW Controller, Foot, Handpiece And Cord

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