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510(k) Data Aggregation

    K Number
    K980633
    Device Name
    ENDOSOLV E
    Manufacturer
    SPECIALITES SEPTODONT
    Date Cleared
    1998-05-01

    (71 days)

    Product Code
    KIF
    Regulation Number
    872.3820
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    K172839
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Softening and removal of root canal fillings

    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 device called "ENDOSOLV E." This document primarily addresses the regulatory approval of the device and confirms its substantial equivalence to a predicate device.

    It does not contain any information regarding specific acceptance criteria, study details, performance metrics, sample sizes, expert qualifications, or ground truth establishment. The document is a regulatory communication, not a performance study report.

    Therefore, I cannot fulfill your request for the information outlined in the prompt based on the provided text.

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