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510(k) Data Aggregation

    K Number
    K041098

    Validate with FDA (Live)

    Device Name
    COOL TEMP NATURAL
    Manufacturer
    COLTENE AG
    Date Cleared
    2004-05-13

    (16 days)

    Product Code
    EBG
    Regulation Number
    872.3770
    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

    Coltène Cool Temp Natural, in Vita® shades A1, A2 and A3.5, is indicated for temporary crown- and bridge restorations used for all techniques, i.e. with matrices or templates as well as Direct application in the dental laboratory.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental material (Cool Temp Natural), not a study report for an AI/ML medical device.

    Therefore, I cannot extract any information about acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study details as requested. The document does not contain any of these elements.

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