LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K992582
    Device Name
    PACIFIC IMPLANT TITANIUM ENDODONTIC POINT
    Manufacturer
    PACIFIC IMPLANT, INC.
    Date Cleared
    1999-10-21

    (80 days)

    Product Code
    EKL
    Regulation Number
    872.3840
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Pacific Implant Titanium Endodontic Point is intended for use during endodontic therapy to fill permanently the root canal of a tooth.

    Device Description

    The product is a titanium endodontic point having the same intended use as endodontic silver points; i.e. to be used during endodontic therapy to fill permanently the root canal of a tooth. The device is fabricated in various endodontic point sizes of titanium CP meeting the ASTM F 67 standard specification for unalloyed titanium for surgical implant applications.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) summary for a dental device (Pacific Implant Titanium Endodontic Point) and a letter from the FDA determining its substantial equivalence to previously marketed devices. It focuses on regulatory approval and classification rather than performance studies or acceptance criteria for a specific device feature or function.

    Therefore, I cannot provide the requested table or answer the questions regarding sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, or training set details. This information is simply not present in the given text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1