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510(k) Data Aggregation

    K Number
    K973776
    Device Name
    REFLECTIONS
    Manufacturer
    CDB CORP.
    Date Cleared
    1997-11-21

    (49 days)

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

    CDB CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Orthodontic brackets are usually cemented to the front surface of the tooth where they direct the mechanical forces that urge teeth into correct alignment. A curved arch wire that is bent or twisted to a particular prescription before installation is forced into a slot in each bracket. The resulting torque or restoring force causes the teeth to shift into the desired alignment. Depending on the shape and twist of the arch wire and the orientation of the bracket slot, it is possible to apply forces, which can shift, rotate, or tip the teeth in any desired direction.
    Device Description
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