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510(k) Data Aggregation

    K Number
    K040573
    Date Cleared
    2004-04-28

    (55 days)

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

    NOBEL BIOCARE PERMANENT CENTRIC POST, MODELS 31234, 31235, 31236

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

    The Nobel Biocare Permanent Centric Post is a support component indicated for use as both an alignment post to center an abutment, and as a seal to prohibit fluids from seeping into the implant interior.

    The Nobel Biocare Permanent Centric Post is a component within the endosseous implant system, and is intented for use in permanent restorations in order to restore the chewing function of fully edentulous and/or partially edentulous patients.

    Device Description

    Nobel Biocare's Permanent Centric Post is a hollow, accessory component designed to enhance the performance of the implant/abutment system by ensuring proper alignment between an abutment and an endosseous implant, while additionally acting as a seal that prevents fluids from seeping into the implant interior.

    The Nobel Biocare Permanent Centric Post does not contact any mucous membranes in the oral cavity because it rests inside the implant/abutment interface. The Centric Post can only be used as part of the implant system, not on its own. It is designed to remain inside the implant/abutment interface for as long as the implant remains in the patient's mouth.

    AI/ML Overview

    This document is a 510(k) summary for the Nobel Biocare Permanent Centric Post, a dental device. It does not contain information about acceptance criteria or a study proving that the device meets those criteria. Instead, it describes the device, its indications for use, and its substantial equivalence to a predicate device.

    Therefore, I cannot provide the requested information based on the provided text. The document is a regulatory submission, not a scientific study report.

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