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510(k) Data Aggregation

    K Number
    K041272
    Device Name
    DYRACT CEM PLUS CEMENT
    Manufacturer
    DENTSPLY INTL.
    Date Cleared
    2004-10-18

    (159 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K933139,K982395
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    DYRACT® CEM PLUS CEMENT is indicated for: 1) Cementation of conventional metal or porcelain-fused-to-metal inlays, crowns, bridges, posts and post-core units: 2) Adhesive cementation of porcelain, composite, or all-ceranic inlays, onlays and crowns; and 3) Cementation of all-zirconia bridges.

    Device Description

    DYRACT® CEM PLUS CEMENT is a dental luting cement (powder/liquid system) that combines the major benefits of glass ionomer cements--adhesion to tooth substance and fluoride release--with the mechanical strength of a luting composite.

    AI/ML Overview

    The provided text is related to a 510(k) premarket notification for a dental luting cement called DYRACT® CEM PLUS CEMENT. It establishes substantial equivalence to predicate devices and outlines the intended uses and technological characteristics. However, it does not contain any information about acceptance criteria, device performance, study designs, sample sizes, expert involvement, or any form of clinical or performance study details relevant to the questions asked.

    Therefore, I cannot extract the requested information from the provided text. The document is primarily an FDA communication approving market access based on substantial equivalence, not a detailed study report.

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