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    K Number
    K993717
    Device Name
    ENIGMA HI-BASE DENTURE BASE MATERIAL
    Manufacturer
    DAVIS SCHOTTLANDER & DAVIS, LTD.
    Date Cleared
    1999-12-22

    (49 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ENIGMA HI-BASE DENTURE BASE MATERIAL

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

    ENIGMA denture base is to be used in conjunction with denture teeth in 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

    Schottlander ENIGMA HI-BASE Denture base material

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details (sample size, data provenance, expert ground truth, adjudication method, MRMC study, standalone performance, training set details), or the type of ground truth used.

    The document is an FDA 510(k) clearance letter for a dental device (Enigma Hi Base Denture-Base Material), indicating that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory classifications, general controls, and compliance requirements. Attachment #4 provides the "INDICATIONS FOR USE" for the device.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

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