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510(k) Data Aggregation

    K Number
    K160800
    Device Name
    DuoCem
    Manufacturer
    COLTENE/WHALEDENT AG
    Date Cleared
    2016-11-16

    (238 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

    DuoCem is indicated for:

    • permanent cementing of crowns, inlays, onlays (ceramic, metal, composite)
    • permanent cementing of root posts of all types
    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding a dental cement called DuoCem. It determines substantial equivalence for the device based on its indications for use.

    Crucially, the provided text does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement. This document is a regulatory approval letter, not a scientific study report.

    Therefore, I cannot answer the requested questions with the given input.

    To answer those questions, I would need a different document, such as:

    • A clinical study report
    • A performance testing report
    • A premarket notification (510(k)) summary that includes detailed performance data.
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