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510(k) Data Aggregation

    K Number
    K962031
    Device Name
    QUANTEC SERIES 2000 ENDODONTIC FILES
    Manufacturer
    TYCOM DENTAL
    Date Cleared
    1996-06-04

    (11 days)

    Product Code
    EKS
    Regulation Number
    872.4565
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K933582,K943584
    Why did this record match?
    Device Name :

    QUANTEC SERIES 2000 ENDODONTIC FILES

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

    The Quantec Series 2000 Endodontic Files are designed for use in root canal preparation.

    Device Description

    The Quantec Series 2000 Endodontic Files are a series hand driven and engine (rotary) driven endodontic files for use in root canal preparation. The files are constructed of nickel-titanium and color coded for ease of use. The files are available in 17, 21 and 25mm lengths and ten graduating sizes.

    AI/ML Overview

    This document is a 510(k) summary for the Quantec Series 2000 Endodontic File and does not contain information about acceptance criteria or a study proving device performance against such criteria.

    The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices (Tulsa Dental Profile 29 Series and Dentsply SureFlex Endodontic Files) based on intended use and technological characteristics. It does not include performance metrics or clinical study results typical for establishing acceptance criteria for AI/algorithm-based devices.

    Therefore, I cannot provide the requested information in the format of a table or answer the specific questions about sample sizes, ground truth, experts, or MRMC studies, as these details are not present in the provided text.

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