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510(k) Data Aggregation

    K Number
    K222847
    Device Name
    Ceramic Brackets Orthometric
    Manufacturer
    Orthometric - Industria e Comercio de Produtos Medicos
    Date Cleared
    2023-05-04

    (225 days)

    Product Code
    NJM
    Regulation Number
    872.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    Orthometric - Industria e Comercio de Produtos Medicos

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ceramic Brackets Orthometric are intended for use in orthodontic treatment. The brackets are affixed to teeth so that pressure can be exerted on the teeth.
    Device Description
    The Orthometric's Ceramic Brackets are composed of different designs of brackets that are made of Aluminum Oxide. The ceramic brackets are ICERAM, ICERAM-P, and ICE CLEAR.
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