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510(k) Data Aggregation

    K Number
    K112707
    Device Name
    GENERATION C AESTHETIC SELF-LIGATING BRACKET SYSTEM
    Manufacturer
    ORTHO TECHNOLOGY, INC
    Date Cleared
    2012-01-13

    (116 days)

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

    ORTHO TECHNOLOGY, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Generation CTM Aesthetic Self-Ligating Bracket System indication for use is to correct malocclusions of the teeth as determined by a licensed Orthodontist/Dentist. The brackets are intended to only be bonded to natural teeth. The brackets are used with orthodonic wire to control the direction of the tooth movement of the individual teeth by providing a slow and continuous force to the teeth.
    Device Description
    Generation CTM Aesthetic Self-Ligating Bracket System
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    K Number
    K073045
    Device Name
    SAPPHIRE CERAMIC BRACKET
    Manufacturer
    ORTHO TECHNOLOGY, INC
    Date Cleared
    2007-12-18

    (50 days)

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

    ORTHO TECHNOLOGY, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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