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510(k) Data Aggregation

    K Number
    K060334
    Device Name
    GI DENTSTAT
    Manufacturer
    ULTRADENT PRODUCTS, INC.
    Date Cleared
    2006-02-23

    (14 days)

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

    GI DentStat serves as a fluoride releasing temporary tooth filling or as a base cement to be applied i a tooth to protect the tooth pulp.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a dental cement called "GI DentStat." It does not contain any information about acceptance criteria, device performance, study designs, sample sizes, ground truth establishment, or expert qualifications related to an AI/ML medical device.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this document is not relevant to such a request for an AI/ML device.

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