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510(k) Data Aggregation

    K Number
    K031461
    Device Name
    CARRIER TIPS
    Manufacturer
    DENTSPLY INTL.
    Date Cleared
    2003-08-05

    (89 days)

    Product Code
    ELC,KIF
    Regulation Number
    872.4850
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K960889
    Why did this record match?
    Device Name :

    CARRIER TIPS

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

    Used to deliver ProRoot® MTA Material in surgical and non-surgical dental applications in conjunction with an ultrasonic unit.

    Device Description

    The CARRIER TIPS are stainless steel ultrasonic tips used to deliver pre-mixed ProRoot® MTA Material to a prepared dental site on the tooth and fill that site as part of an endodontic procedure. There are two tip designs - one for surgical type procedures and one for non-surgical type procedures. These tips and a sleeve are attached to a standard piezo electric ultrasonic scaling unit handpiece. In between placement of the Material, standard hand instruments are used to condense and compact the Material.

    AI/ML Overview

    The provided text is a 510(k) premarket notification for the "CARRIER TIPS" device. It outlines the device's description, intended use, and technological characteristics compared to a predicate device. However, it does not contain any information about acceptance criteria, a study proving device performance against those criteria, or details regarding ground truth establishment, sample sizes, or expert qualifications.

    The document is a submission for substantial equivalence to a legally marketed predicate device, meaning the manufacturer is asserting their device is as safe and effective as an existing device. This type of submission typically relies on demonstrating similarity in materials, technology, design, and intended use, rather than presenting a detailed clinical study with performance metrics and acceptance criteria as would be found in a PMA (Premarket Approval) application or a clinical trial report.

    Therefore, I cannot fulfill the request to provide the acceptance criteria and study details based on the provided text. The document's purpose is to declare substantial equivalence, not to present performance data against specific acceptance criteria.

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