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510(k) Data Aggregation

    K Number
    K040144
    Device Name
    QUIXX POSTERIOR RESTORATIVE
    Manufacturer
    DENTSPLY INTERNATIONAL
    Date Cleared
    2004-04-01

    (70 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K973235,K973221
    Why did this record match?
    Reference Devices :

    K973235,K973221

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

    QUIXX™ POSTERIOR RESTORATIVE is indicated for posterior Class I and II cavities.

    Device Description

    QUIXX™ POSTERIOR RESTORATIVE is a hybrid resincomposite restorative material for use in filling posterior dental cavities. The restorative consists of a single paste that is visible light cured.

    AI/ML Overview

    This document is a 510(k) premarket notification for a dental restorative material, not a study evaluating an AI-powered medical device. Therefore, it does not contain the information required to answer the questions about acceptance criteria, study design, expert involvement, and AI performance.

    The document describes a conventional dental product, "QUIXX™ POSTERIOR RESTORATIVE," and its technological characteristics and intended use, comparing it to predicate devices. It discusses biocompatibility testing (cytotoxicity and mutagenicity) but does not involve any AI components or a study comparing its performance against specific acceptance criteria in the manner requested.

    Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, expert qualifications, or AI-related study findings from the provided text.

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