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510(k) Data Aggregation

    K Number
    K011762
    Device Name
    HI-WAVE; POUR-PLUS
    Manufacturer
    DENPLUS, INC.
    Date Cleared
    2001-08-23

    (77 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    HI-Wave is a 3 minutes microwave heat curing acrylic and Pour-Plus is a color stable auto-curing acrylic for use in the fabrication of complete or partial removable dentures.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for two dental devices, "Hi-Wave" and "Pour-Plus" denture base acrylics. It does not contain any information regarding acceptance criteria, device performance, sample sizes used in studies, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

    Therefore, I cannot provide the requested table or answer the specific questions about the device's acceptance criteria and the study proving it meets those criteria. The document only states that the devices are substantially equivalent to legally marketed predicate devices.

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