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510(k) Data Aggregation

    K Number
    K014142
    Device Name
    UNITE BONDING ADHESIVE
    Manufacturer
    3M UNITEK
    Date Cleared
    2002-02-28

    (73 days)

    Product Code
    DYH
    Regulation Number
    872.3750
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    UNITE BONDING ADHESIVE

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

    Unite Bonding Adhesive is indicated for bonding orthodontic appliances to teeth for orthodontic treatment.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA to a medical device manufacturer, 3M Unitek, regarding their "Unite Bonding Adhesive." This document primarily addresses the substantial equivalence determination of the device and regulatory compliance.

    The document does not contain any information about:

    • Acceptance criteria for device performance.
    • The study that proves the device meets acceptance criteria (including details like sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details).

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria based on the provided text. This type of information is typically found in the 510(k) summary or the full 510(k) submission, neither of which is present here.

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