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510(k) Data Aggregation

    K Number
    K042658
    Device Name
    PROCERA ABUTMENT BRANEMARK, MODELS 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004
    Manufacturer
    NOBEL BIOCARE UAS INC
    Date Cleared
    2004-10-20

    (22 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K031719,K974150,K913255,K032263,K954512,K011038,K981516
    Predicate For
    K051501,K052070,K052823,K061478,K061529,K073217,K083192,K091756,K091904,K103252
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Nobel Biocare's Procera® Abutment Brånemark is indicated for the treatment of partially edentulous patients requiring a prosthetic device. In addition to the Brånemark implant, the abutment's hexagon connector fits the external hexagon of the following endosseous implants:

    • 3i® 3.75
    • Lifecore® Biomedical Restore 3.75
    • Zimmer® Dental Taperlock 4.0
    • Sterngold Implamed® 3.75
    Device Description

    The Procera® Abutment Brânemark is an artificial tooth abutment designed to fit and function on root-form endosseous implants having an external hexagon abutment interface.
    Nobel Biocare's Procera® Abutment Brånemark is intended for use in the treatment of partially edentulous patients in arder to restore chewing function. The Procera® Abutment Brånemark is a prosthetic device panonto in brace's Brånemark external hexagon endosseous implant as well as the endosseous implants specifically indicated. The device has been developed for long-term, permanent use.
    Nobel Biocare's Procera® Abutment Brånemark can be made from titanium, alumina, or zirconia.

    AI/ML Overview

    The provided text is a 510(k) summary for the Nobel Biocare Procera® Abutment Brånemark. It details the device description, indications for use, and a statement that "The Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and The Class II Special Controls Guidance Document: Root Porn Lindoseous Beach (May 12, 2004) was identified as applicable to this submission."

    However, this document does not contain any information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, data provenance, expert ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, or training set details.

    The document is a regulatory submission for a dental implant abutment, focused on demonstrating substantial equivalence to previously marketed devices. It does not include the type of performance study details requested in your prompt.

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