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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
    Why did this record match?
    Applicant Name (Manufacturer) :

    Bonart Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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)
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    K Number
    K152125
    Device Name
    Oral Surgery System and Accessories
    Manufacturer
    BONART CO., LTD.
    Date Cleared
    2016-08-15

    (381 days)

    Product Code
    DZI
    Regulation Number
    872.4120
    Why did this record match?
    Applicant Name (Manufacturer) :

    BONART CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bonart Oral Surgery System is intended for use in oral surgery and dental implantology,
    Device Description
    ARTeotomy ORAL SURGERY SYSTEM and ACCESSORIES (Model No. BIS)
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