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510(k) Data Aggregation

    K Number
    K070190
    Device Name
    GRADIA DIRECT X
    Manufacturer
    GC AMERICA INC.
    Date Cleared
    2007-03-12

    (49 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This product is a light-cured micro-filled composite resin for use in the following recommended indications: Direct restorative for Class I and II cavities.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a medical device called "Gradia Direct X." This document is a regulatory approval, not a scientific study report. It states that the device is substantially equivalent to legally marketed predicate devices.

    Therefore, the document does not contain the information requested regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness studies.

    The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This indicates that the approval is based on a comparison to existing devices, not a new study demonstrating performance against specific acceptance criteria in the manner requested.

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