LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K050641
    Device Name
    ZYGOMA TIUNITE
    Manufacturer
    NOBEL BIOCARE USA LLC
    Date Cleared
    2005-04-07

    (24 days)

    Product Code
    NHA,DZE
    Regulation Number
    872.3630
    Type
    Special
    Panel
    Dental
    Reference & Predicate Devices
    K050641
    Why did this record match?
    Device Name :

    ZYGOMA TIUNITE

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

    Nobel Biocare's Zygoma TiUnite® is a titanium, endosseous implant with components intended to be placed in the upper jaw in order to provide support for prosthetic devices such as artificial teeth in order to restore patient esthetics and chewing function.

    Device Description

    Nobel Biocare's Zygoma TiUnite® includes endosseous implants, a cover screw, healing abutments, and multi-unit abutments.

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) premarket notification letter from the FDA to Nobel Biocare USA, LLC for a dental implant named "Zygoma TiUnite". It confirms substantial equivalence to predicate devices and outlines regulatory requirements.

    Therefore, I cannot extract the requested information, including:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes and data provenance for a test set.
    3. Number and qualifications of experts for ground truth.
    4. Adjudication method.
    5. MRMC comparative effectiveness study results.
    6. Standalone algorithm performance.
    7. Type of ground truth used.
    8. Sample size for the training set.
    9. Method for establishing training set ground truth.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1