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510(k) Data Aggregation

    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
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Oral Surgery System and Accessories

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

    AI/ML Overview

    The provided FDA document, K152125 for the "ARTeotomy Oral Surgery System and Accessories (Model No. BIS)", is a 510(k) premarket notification and focuses on establishing substantial equivalence to a predicate device. This type of document does not contain details about acceptance criteria, specific device performance metrics, or study designs (including sample sizes, ground truth establishment, or expert involvement) typically found in clinical validation studies for AI/software-as-a-medical-device (SaMD) products.

    The document primarily states that the device is intended for "oral surgery and dental implantology" and has been determined to be substantially equivalent to a legally marketed predicate device.

    Therefore, based solely on the provided text, I cannot extract the requested information. The document serves as an FDA clearance letter, not a detailed study report.

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