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510(k) Data Aggregation

    K Number
    K150601
    Device Name
    Zeramic Adhesive Resin Cement
    Manufacturer
    Premier Dental Company Products
    Date Cleared
    2015-07-22

    (134 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Zeramic Adhesive Resin Cement is a prescription only, dual cured, radiopaque resin cement intended to be used for cementation of porcelain, ceramic, resin, metal-based inlays/onlays, crowns, bridges, core build up material, posts and veneers. It is also used for cementation of crown restorations to implants.

    Device Description

    Not Found

    AI/ML Overview

    The FDA letter provided refers to the Zeramic Adhesive Resin Cement (K150601). While it mentions general regulatory information, it does not contain details about specific acceptance criteria or the studies performed to demonstrate the device meets these criteria.

    The letter is a notification of substantial equivalence based on a 510(k) submission, meaning the FDA determined the device is as safe and effective as a legally marketed predicate device. The information requested regarding acceptance criteria, study design, sample sizes, expert ground truth, and comparative effectiveness studies would typically be found within the 510(k) summary or the full 510(k) submission document itself, which are not included in the provided text.

    Therefore, I cannot provide the requested information based solely on the provided document. The document primarily focuses on regulatory approval and classification rather than the technical details of device performance testing.

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