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510(k) Data Aggregation

    K Number
    K973694
    Device Name
    PROVIL NOVO
    Manufacturer
    HERAEUS KULZER, INC.
    Date Cleared
    1997-11-24

    (59 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Provil novo is a silicone based, addition curing impression material used for all inlay, crown and bridge, edentulous a partial impressions.

    Device Description

    Provil novo is a silicone based, addition curing impression material.

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA related to a 510(k) premarket notification for a dental impression material named "Provil novo". It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory responsibilities.

    The document does not contain any information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth establishment. Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on this input.

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