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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
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    REFLECTIONS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or ground truth establishment. The document is a 510(k) clearance letter from the FDA, approving a dental device (orthodontic brackets) for marketing. It discusses the regulatory process and general compliance but does not include any technical study results or performance metrics. Therefore, I cannot fulfill your request for this specific input.

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