LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K071981
    Device Name
    BONART MODEL ART-P6 PIEZO ELECTRIC ULTRASONIC SCALER & ACCESSORIES (TIPS)
    Manufacturer
    BONART CO. LTD.
    Date Cleared
    2007-10-26

    (100 days)

    Product Code
    ELC
    Regulation Number
    872.4850
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BONART MODEL ART-P6 PIEZO ELECTRIC ULTRASONIC SCALER & ACCESSORIES (TIPS)

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

    ART-P6 Piczo Electric Ultrasonic Scaler is intended for use by medical professionals during dental cleaning and periodontal therapy to remove calculus and tartar deposits and stains from teeth using the application of an ultrasonically vibrating frequency through a stainless steel tip dental accessory called "Tip". Tip comes in various shapes (BS1, BS2, BS3 etc.) and is designed to generate a vibrating frequency of 29Khz,

    Device Description

    BONART ART-P6 PIEZO ELECTRIC ULTRASONIC SCALER & ACCESSORIES (TIPS)

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA regarding the Bonart Art-P6 Piezo Electric Ultrasonic Scaler & Accessories (Tips). It does not contain information about acceptance criteria, device performance studies, or ground truth establishment.

    Therefore, I cannot provide the requested information. The letter only states that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It does not include details of performance testing or clinical studies that would be necessary to answer your questions.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1