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510(k) Data Aggregation

    K Number
    K013185
    Device Name
    TCM ENDO III
    Manufacturer
    NOUVAG AG
    Date Cleared
    2001-11-28

    (65 days)

    Product Code
    EFA
    Regulation Number
    872.4200
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    TCM ENDO III

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

    The TCM Endo III is an AC-powdered endodontic unit consisting of a controller console, foot pedal and motor intended to drive dental handpieces during root canal preparation.

    Device Description

    The TCM Endo III is an AC-powdered endodontic unit consisting of a controller console, foot pedal and motor intended to drive dental handpieces during root canal preparation. The motor has a maximum 1:1 drive output of 16,000 Rpm's. The unit is supplied with either a 115V or 230V power cord. The entire motor assembly of the TCM Endo III is autoclavable.

    AI/ML Overview

    The provided text is a 510(k) summary for the TCM Endo III, an AC-powered dental handpiece. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain any information regarding acceptance criteria, study details, performance metrics, sample sizes, ground truth establishment, or expert involvement that would be required to answer the specific questions posed.

    Therefore, I cannot provide the requested information from the given text. The document is a regulatory submission for market clearance based on substantial equivalence, not a performance study report.

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