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510(k) Data Aggregation

    K Number
    K993835
    Device Name
    PARAPOST SYSTEM STERILIZABLE ORGANIZER
    Manufacturer
    COLTENE/WHALEDENT INC.
    Date Cleared
    1999-12-16

    (34 days)

    Product Code
    FRG
    Regulation Number
    880.6850
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ParaPost System Sterilizable Organizer (The Organizer) is used for the ultrasonic cleaning and subsequent steam sterilizing (autoclaving) of contaminated dental/medical instruments and devices (accessory devices, endodontic files and reamers, drills and burs as well as endodontic posts). in a 132°C gravity cycle for 12 minutes.

    Device Description

    The ParaPost System Sterilizable Organizer (The Organizer) is used for the ultrasonic cleaning and subsequent steam sterilizing (autoclaving) of contaminated dental/medical instruments and devices (accessory devices, endodontic files and reamers, drills and burs as well as endodontic posts).

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (ParaPost System Sterilizable Organizer). It does not contain information about acceptance criteria, device performance, study details, sample sizes, or ground truth establishment. This document is a regulatory approval, not a scientific study report.

    Therefore, I cannot extract the requested information to fill the table and answer the questions.

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