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510(k) Data Aggregation

    K Number
    K964944
    Device Name
    ROUND DENTAL BUR
    Manufacturer
    STERI-OSS, INC.
    Date Cleared
    1997-02-10

    (62 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The intended use is to cut hard structures in the mouth, such as teeth or bone. One such application is to cut holes in cortical plate bone preparatory to creation of an osteotomy for placement of dental implants.

    Device Description

    Dental burs are rotary cutting devices. Dental burs are shaped to provide a cutting action when simultaneously rotating and advanced forward into the target material with the application of pressure. Round Dental Burs are manufactured from carbide steel or tungsten carbide and may have friction grip or right anlge latch shanks.

    AI/ML Overview

    This 510(k) submission for the Steri-Oss Round Dental Bur does not include any information about acceptance criteria or a study proving the device meets them, because it is a traditional medical device and not an AI/ML powered device.

    Therefore, I cannot provide the requested information in the format of a table or answer the specific questions related to AI/ML device performance and validation.

    The submission claims substantial equivalence to Brasseler Corporation's Round Dental Burs and relies on a comparison of design, material, and packaging characteristics, not performance data or AI/ML-related metrics. The document explicitly states "Performance Data: Not applicable."

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