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510(k) Data Aggregation

    K Number
    K020394
    Device Name
    APC PLUS ADHESIVE
    Manufacturer
    3M UNITEK
    Date Cleared
    2002-04-12

    (65 days)

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

    APC PLUS ADHESIVE

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

    3M™ Unitek™ APC™ Plus Adhesive is indicated for use in orthodontic appliance application and bonding for orthodontic treatment.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the necessary information to answer your request. The document is an FDA 510(k) clearance letter for a dental adhesive (3M™ Unitek™ APC™ Plus Adhesive). It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory requirements. However, it does not include any details about acceptance criteria for performance, studies demonstrating performance, sample sizes, expert qualifications, adjudication methods, or ground truth establishment. These details are typically found in the 510(k) submission itself or in associated studies, not in the clearance letter.

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