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510(k) Data Aggregation

    K Number
    K091848
    Manufacturer
    Date Cleared
    2009-10-16

    (116 days)

    Product Code
    Regulation Number
    872.3630
    Panel
    Dental
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    NOBEL/PROCERA IMPLANT BRIDGE

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

    The NobelProcera Implant Bridge is indicated for use as a bridge framework in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.

    Device Description

    Nobel Biocare's NobelProcera Implant Bridge is a bridge framework that attaches to implants or abutments. The NobelProcera Implant Bridge is intended to be finished into a dental prosthesis using standard laboratory dental materials such as resin composite or porcelain veneer.

    NobelProcera Implant Bridges are made individually following instructions and models specific to each patient. The NobelProcera Implant Bridge is made entirely of titanium.

    AI/ML Overview

    This document is a 510(k) summary for the NobelProcera Implant Bridge, a dental device. It outlines the device description, indications for use, and its substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.

    Therefore, I cannot provide the requested table and information based solely on the provided text. The provided text is a regulatory submission for premarket notification, which focuses on device description and substantial equivalence, not detailed performance studies or clinical trial results.

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