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510(k) Data Aggregation

    K Number
    K022975
    Device Name
    ETCHING 15
    Manufacturer
    AB ARDENT
    Date Cleared
    2002-11-22

    (77 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ETCHING 15

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

    E.TCHING 15 is used in the enamel or total etch techniques for Composite restorations Adhesive cementation of inlays (composite and ceramic)crowns, bridges, eneers, adhesive bridges and root posts. Splints Bonding of orthodontic attachments Fissure sealings

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA to AB Ardent for their device ETCHING 15. It details the regulatory approval process and general controls applicable to the device. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.

    Therefore, I cannot provide the requested table or information based on the provided text.

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