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510(k) Data Aggregation

    K Number
    K081550
    Device Name
    BONART ULTRASONIC SCALER, MOEDLS ART-P3II PRO AND ART-MII PRO
    Manufacturer
    BONART CO. LTD.
    Date Cleared
    2008-08-28

    (86 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 ULTRASONIC SCALER, MOEDLS ART-P3II PRO AND ART-MII PRO

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

    ART-P31! Pro Multi-function piezoelectric Ultrasonic system is intended for use by medical professionals during denral 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 t p dental accessory called "Tip". Tip comes in various shapes (BS1, BS2, B53 etc.) and is designed to generate a vibrating frequency of 29Khz.

    ART-M311 Pro Multi-function-Magnet Ultrasonic System is intended for use by medical professionals during demal 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 "Insert comes in various shapes (ART P-10, ART SLI-P100, ART IF50 etc.) and is designed to generate a vibrating frequency of 24.5KHz. ±5%.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA for a dental ultrasonic scaler. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria.

    Specifically, the document does not include:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes or data provenance for any test sets.
    3. Number or qualifications of experts used for ground truth.
    4. Adjudication methods.
    5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
    6. Information about standalone algorithm performance.
    7. The type of ground truth used (e.g., pathology, outcomes data).
    8. Sample size for the training set.
    9. How ground truth for the training set was established.

    This document is a regulatory approval letter based on substantial equivalence to predicate devices, not a detailed report of performance studies against specific acceptance criteria.

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