BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇧🇷 Brazil

    Maxima PRO 45L

    K Number: K141576 · Decision May 4, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    260
    Applicant Total
    1
    Review Days
    326

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    Basic Information

    Device Name
    Maxima PRO 45L
    K Number
    K141576
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kavo DO Brasil Industria E Comercio Ltda
    Date Received
    June 12, 2014
    Decision Date
    May 4, 2015
    Product Code
    EFB
    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
    EFB Handpiece, Air-Powered, Dental

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