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510(k) Data Aggregation

    K Number
    K090716
    Device Name
    BEGO SEMADOS S-LINE
    Manufacturer
    BEGO IMPLANT SYSTEMS GMBH & CO. KG
    Date Cleared
    2009-10-06

    (202 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K032158
    Why did this record match?
    Device Name :

    BEGO SEMADOS S-LINE

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

    The Bego Semados® S-line threaded endosseous dental implants are indicated for restorations in the upper and lower jaw (single tooth replacement, abutments for bridgework, partial or complete edentolism)

    Device Description

    BEGO Semados® S-Line with TiPure"155 Surface is a dental implant system that can be placed subgingivally in both the upper and lower jaw using a one- or two-stage surgical procedure.

    AI/ML Overview

    The provided text does not contain any information about acceptance criteria, device performance, specific studies with sample sizes, or expert adjudication for the BEGO Semados® S-Line.

    The document is a 510(k) premarket notification summary, which primarily establishes substantial equivalence to a legally marketed predicate device (XIVE Dental Implant System® K032158) rather than detailing performance studies with specific metrics.

    Therefore, I cannot fulfill the request for information regarding acceptance criteria and the study that proves the device meets them based on the provided text. The document focuses on regulatory approval based on equivalence and indications for use.

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