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    K Number
    K012427
    Device Name
    PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT
    Manufacturer
    SPECIALITES SEPTODONT
    Date Cleared
    2001-10-09

    (70 days)

    Product Code
    EAT
    Regulation Number
    872.1720
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K830105
    Why did this record match?
    Device Name :

    PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT

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

    Pharmaéthyl® Local pulp and vitality testing agent is indicated as topical pulp and tooth vitality testing agent.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the device "Pharmaethyl Local Pulp and Vitality Testing Agent" and its Indications for Use statement. However, it does not contain any information about acceptance criteria, device performance, study details (sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance), or training set information.

    This document is a regulatory approval, stating that the device is substantially equivalent to a predicate device, and does not include the technical study report that would contain the requested information.

    Therefore, I cannot provide the requested table and study details based on the input text.

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