BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇧🇷 Brazil

    Ceramic Brackets Orthometric

    K Number: K222847 · Decision May 4, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    59
    Applicant Total
    1
    Review Days
    225

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    Basic Information

    Device Name
    Ceramic Brackets Orthometric
    K Number
    K222847
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.5470
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Orthometric - Industria E Comercio DE Produtos Medicos
    Date Received
    September 21, 2022
    Decision Date
    May 4, 2023
    Product Code
    NJM
    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
    NJM Bracket, Ceramic, Orthodontic

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