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510(k) Data Aggregation

    K Number
    K022097
    Device Name
    THERMIQUE
    Manufacturer
    PARKELL, INC.
    Date Cleared
    2002-09-06

    (71 days)

    Product Code
    EAT
    Regulation Number
    872.1720
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    THERMIQUE

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

    For use during condensation of gutta percha in tooth root canals. May also be used as a pulp r of use during ochaoned. Of Samal stimulus through molten gutta percha.

    Device Description

    Thermique Thermal Condenser

    AI/ML Overview

    The provided text is a 510(k) premarket notification approval letter for the "Thermique Thermal Condenser." This document focuses on establishing substantial equivalence to a predicate device and does not contain information about the device's specific acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert qualifications. It is a regulatory approval document, not a clinical study report.

    Therefore, I cannot provide the requested information from the given input.

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