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510(k) Data Aggregation

    K Number
    K110484
    Device Name
    SELF CURE TEMPORARY CROWN AND BRIDGE MATERIAL
    Manufacturer
    NOVOCOL, INC.
    Date Cleared
    2011-05-17

    (88 days)

    Product Code
    EBG
    Regulation Number
    872.3770
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    "Self Cure Temporary Crown and Bridge Material" is indicated for the fabrication of temporary crown, partial crown, inlay, onlay and/or bridges.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a medical device called "Self Cure Temporary Crown and Bridge Material." This type of document does not typically contain the detailed information required to describe acceptance criteria and the specifics of a study proving a device meets those criteria, especially for software-based or AI/ML devices.

    The 510(k) letter primarily states that the device is substantially equivalent to a predicate device and is intended for the fabrication of temporary crowns, partial crowns, inlays, onlays, and/or bridges.

    Therefore,Based on the provided document, I cannot extract the information required to populate the table and answer the questions regarding acceptance criteria and the study details. This document is a regulatory approval letter, not a study report.

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