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510(k) Data Aggregation

    K Number
    K162856
    Device Name
    Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE)
    Manufacturer
    Bonart Co., Ltd.
    Date Cleared
    2017-07-18

    (279 days)

    Product Code
    EGS
    Regulation Number
    872.4200
    Type
    Abbreviated
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE)

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

    Bonart dental hand piece is used for removing carious material, cavity and crown preparations, finishing tooth preparations, reducing hard tooth structures, restorations.

    Device Description

    Bonart Dental Handpieces (ART), Disposable Prophy Angle (PERFORMANCE)

    AI/ML Overview

    The provided text is a 510(k) summary from the FDA for Bonart Dental Handpieces (ART) and Disposable Prophy Angle (PERFORMANCE). It is a letter of substantial equivalence and does not contain details about acceptance criteria, study methodologies, or performance results. This document is a regulatory approval, not a scientific study report.

    Therefore, I cannot extract the requested information as it is not present in the provided text.

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