LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K992233
    Device Name
    APEX LOCATOR BINGO-1020
    Manufacturer
    DENT CORP. RESEARCH & DEVELOPMENT
    Date Cleared
    1999-11-30

    (158 days)

    Product Code
    LQY
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    APEX LOCATOR BINGO-1020

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

    BINGO-1020 is a modern device for precise apex localization during root channel treatment.

    Device Description

    BINGO-1020 is distinguished by increasing precision at 0.1mm on wet/dry, large graphic display where current position of endo file is reflected and other essential information is displayed.

    AI/ML Overview

    I'm sorry, but the provided text from the FDA 510(k) clearance letter for the Apex Locator Bingo-1020 does not contain information about acceptance criteria or a study proving the device meets those criteria.

    The letter focuses on the FDA's determination of substantial equivalence to a predicate device, which allows the device to be marketed. It does not include details about device performance metrics, study designs, sample sizes, ground truth establishment, or expert qualifications.

    Therefore, I cannot fulfill your request for the specific information outlined in points 1 through 9 based on the provided document.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1