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510(k) Data Aggregation

    K Number
    K062305
    Device Name
    CLARITY MODIFIED CERAMIC BRACKETS
    Manufacturer
    3M UNITEK
    Date Cleared
    2006-10-18

    (71 days)

    Product Code
    NJM
    Regulation Number
    872.5470
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CLARITY MODIFIED CERAMIC BRACKETS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Clarity Modified Ceramic Bracket is intended for use in orthodontic treatment.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain any information regarding the acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) clearance letter from the FDA for a device named "Clarity™ Modified Ceramic Brackets," which primarily discusses regulatory aspects and substantial equivalence to legally marketed predicate devices. It does not include details about device performance metrics, study designs, sample sizes, ground truth establishment, or expert qualifications.

    Therefore, I cannot provide the requested information in the table format.

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