LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K974828
    Device Name
    BRANEMARK SYSTEM(R) EBON(TM) FIXTURE
    Manufacturer
    NOBEL BIOCARE UAS INC
    Date Cleared
    1998-03-24

    (90 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K945398
    Why did this record match?
    Device Name :

    BRANEMARK SYSTEM(R) EBON(TM) FIXTURE

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

    Nobel Biocare's Ebon™ Fixtures are titanium endosseous implants that are intended to be placed in the upper or lower jaw to support prosthetic devices such as artificial teeth and to restore the patient's chewing function. This fixture is not intended for use in type I bone.

    Device Description

    The Nobel Biocare Ebon Fixture™ is an endosseous implant made of grade 1 commercially available titanium and is intended to be placed in the upper or lower jaw bone to support prosthetic devices such as artificial teeth and to restore the patient's chewing function. This system also includes 2 bevel drills.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria, device performance, or a study. The document is a 510(k) summary and approval letter for a dental implant, focusing on substantial equivalence to a predicate device rather than detailed performance study results.

    Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

    The document indicates that the device's technological characteristics are "identical" to predicate products already marketed by Nobel Biocare, and the FDA determined it to be "substantially equivalent." This implies that the device is considered to meet the same safety and effectiveness standards as its predicates, but no specific performance metrics or studies are detailed in this summary.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1