LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K020080
    Device Name
    BONART ART-E1 ELECTROSURGERY UNIT
    Manufacturer
    DIAGNOSTIC DATA, INC.
    Date Cleared
    2002-02-19

    (41 days)

    Product Code
    EKZ
    Regulation Number
    872.4920
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIAGNOSTIC DATA, INC.

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

    The Bonart Co., Ltd. ART-E1 Electrosurgery Unit is intended for use in dental electrosurgery (electrosection), electrosection/electrocoagulation, and electrocoagulation for serious bleeding.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA regarding an electrosurgery unit. It does not contain information about acceptance criteria, device performance, study details (sample size, data provenance, ground truth, expert qualifications, adjudication methods), or AI-related comparative effectiveness or standalone studies.

    Therefore, I cannot provide the requested information based on the provided text. This document is a regulatory approval letter, not a study report.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1