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510(k) Data Aggregation

    K Number
    K041283

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2004-05-28

    (15 days)

    Product Code
    Regulation Number
    872.3920
    Panel
    Dental
    Reference & Predicate Devices
    Predicate For
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Nobel Biocare's Procera® Bridge Zirconia is indicated for use as the core structure of an artificial prosthesis for partially edentulous patients in the need of prosthetic oral reconstruction in order to restore chewing function. The Procera® Bridge Zirconia may be two, three, or four units and are cemented to natural or artificial tooth abulments.

    Device Description

    Nobel Biocare's Procera® Bridge Zirconia is a prefabricated device intended for use as the core structure of an artificial prosthesis for placement in the oral cavity in order to restore chewing function.

    The Procera® Bridge Zirconia may be two, three, or four units and is precision milled. The Procera® Bridge Zirconia can be cemented or bonded to either natural or artificial tooth aburtments it is personalized according to the specific dimensions of the patient's abutments so the bridge precisely fits, and properly functions, in the patient's jaw.

    Nobel Biocare's Procera® Bridge Zirconia is manufactured from one solid piece of densely sintered zirconia.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria and a study proving a device meets them. The document is a 510(k) summary for a dental device (Procera® Bridge Zirconia), primarily focused on regulatory submission details, device description, and indications for use. It states "No special guidance documents, relative to this device, were found," regarding performance standards, implying that specific quantitative acceptance criteria or a dedicated performance study as typically understood in a medical device context are not detailed in this submission.

    Therefore, I cannot provide the requested information in the table or answer the subsequent questions based on the input text.

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