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510(k) Data Aggregation

    K Number
    K984134
    Device Name
    NATURA DENTURE TEETH
    Manufacturer
    DAVIS SCHOTTLANDER & DAVIS, LTD.
    Date Cleared
    1999-02-12

    (86 days)

    Product Code
    ELM
    Regulation Number
    872.3590
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    NATURA DENTURE TEETH

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

    NATURA teeth are to be used in conjunction with denture base resin for the construction of full and partial dentures. For use only by or on the order of a dental professional such as DDS or DMD. Not for use by general public or OTC.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding "Natura Denture Teeth" and an "Indications For Use" statement. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for an AI/CAD medical device.

    Therefore, I cannot extract the requested information from the given input. The document is a regulatory approval letter for a dental product, not a technical report on a diagnostic device's performance.

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