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

    INTRA LUX HEAD 3 LDSY

    K Number: K092446 · Decision Nov 3, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    24
    Applicant Total
    2
    Review Days
    85

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    Basic Information

    Device Name
    INTRA LUX HEAD 3 LDSY
    K Number
    K092446
    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 & Co.
    Date Received
    August 10, 2009
    Decision Date
    November 3, 2009
    Product Code
    EFA
    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
    EFA Handpiece, Belt And/Or Gear Driven, Dental

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