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510(k) Data Aggregation

    K Number
    K023513
    Device Name
    LOGOS JUNIOR DENTAL CHAIR AND UNIT
    Manufacturer
    CASTELLINI S.P.A.
    Date Cleared
    2003-03-26

    (156 days)

    Product Code
    EIA
    Regulation Number
    872.6640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Logos Junior dental unit and accessories are indicated for the provision of dental treatment in the dental operatory by dentists, dental assistants and dental hygienists.

    Device Description

    LOGOS JUNIOR DENTAL CHAIR AND UNIT

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a dental chair and unit (Logos Junior Dental Chair and Unit, K023513). This document is not a study report for an AI/ML medical device. Therefore, it does not contain the information required to answer the questions about acceptance criteria, device performance, study design, or ground truth establishment for such a device.

    The letter explicitly states that the device is a "Dental Operative Unit and Accessories" and its indication for use is "for the provision of dental treatment in the dental operatory by dentists, dental assistants and dental hygienists."

    To answer your questions, I would need a different type of document, specifically a study report or clinical validation report for an AI/ML medical device.

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