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510(k) Data Aggregation

    K Number
    K012180
    Device Name
    A-WEAR
    Manufacturer
    Date Cleared
    2001-09-05

    (55 days)

    Product Code
    Regulation Number
    872.3690
    Panel
    Dental
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    1. Direct or indirect class III, IV, and V restorations.
    2. Diastema closures.
    3. Composite restorations bonded to tooth structure.
    4. Composite restorations bonded to metal.
    5. Composite restorations bonded to composite or fiber-reinforced substructure.
    6. Composite restorations bonded to porcelain.
    7. Direct or indirect veneers.
    Device Description

    A-Wear™ provides the dentist with a composite designed to yield high resistance to wear and abrasion and excellent polishing characteristics. In addition to these properties, Aand ublighty translucent (opacity

    AI/ML Overview

    The provided text is a 510(k) submission for a dental composite material called A-Wear™. While it provides information about the device's intended use and legal marketing status, it does not contain details about specific acceptance criteria and the studies that prove the device meets these criteria in the way you've outlined.

    The document discusses the device's properties (high resistance to wear and abrasion, excellent polishing characteristics, translucent opacity) by description and comparison to a predicate device (Micronew™), but it does not present quantifiable acceptance criteria or study results to demonstrate these claims.

    Therefore, I cannot populate the table or answer most of your detailed questions based solely on the provided text. The information requested typically comes from performance testing sections of a submission, which are not present here.

    However, I can extract the following limited information where available:


    Acceptance Criteria and Device Performance (Based on descriptive claims, no quantitative data available):

    Acceptance CriteriaReported Device Performance
    High resistance to wear and abrasionA-Wear™ is designed to yield high resistance to wear and abrasion.
    Excellent polishing characteristicsA-Wear™ has excellent polishing characteristics.
    OpacityA-Wear™ is *highly translucent (opacity
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