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510(k) Data Aggregation

    K Number
    K191619
    Device Name
    TurboTemp EZ
    Manufacturer
    Date Cleared
    2019-09-11

    (85 days)

    Product Code
    Regulation Number
    872.3770
    Panel
    Dental
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    TurboTemp EZ

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

    TurboTemp EZ is a is a self-cure crown-and-bridge composite indicated for the fabrication of long- and short-term provisional restorations including veneers, inlays/onlays, crowns, bridges and long-span bridges. TurboTemp EZ is also indicated for incorporation of most mechanically anchored attachment components into the acrylic base of a denture, an overdenture, or a partial denture.

    Device Description

    TurboTemp EZ is a provisional resin based material intended to be used for the fabrication of crowns, bridges, inlays, onlays, and veneers. The composite material is provided in a dual-barrel cartridge that when combined in the mixing tip, it is dispensed as a self-curing restorative material.

    AI/ML Overview

    The provided text describes the regulatory clearance of a dental device, "TurboTemp EZ," and includes information relevant to its performance testing and comparison to predicate devices, rather than a study proving the device meets acceptance criteria in terms of algorithm performance for an AI/ML device.

    Based on the content provided, here's an analysis structured according to your request, with the understanding that this is for a physical medical device, not an AI/ML algorithm:

    1. A table of acceptance criteria and the reported device performance

    For a physical dental material, acceptance criteria often relate to physical, chemical, and biological properties, usually benchmarked against industry standards or predicate devices.

    Acceptance Criteria (from predicate/standards)Reported Device Performance (TurboTemp EZ)
    Transverse Strength (Typically >= 100 MPa from predicate/standards)94 MPa
    Water Sorption (Typically
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