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510(k) Data Aggregation

    K Number
    K991996

    Validate with FDA (Live)

    Device Name
    IMPACT-PLUS, IMPACT-20, DP97, DP97-20, DP-POUR AND DP-REPAIR
    Manufacturer
    DENPLUS, INC.
    Date Cleared
    1999-09-08

    (86 days)

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

    IMPACT-PLUS, IMPACT-20, DP97, DP97-20 are heat-cure acrylics for complete and partial denture fabrication. DP-POUR is auto-cure acrylic for complete and partial denture fabrication. DP-REPAIR is auto-cure acrylic for denture repair.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA, along with an "Indications for Use" statement, for dental acrylics. It does not contain any information regarding acceptance criteria, study details, device performance metrics, or ground truth establishment for an AI-powered medical device.

    Therefore, I cannot answer your request based on the provided input. The document is a regulatory approval for a physical product (dental acrylics) and not a study report or technical specification for an AI device.

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