LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K103391
    Device Name
    IVOBASE HYBRID, IVOBASE HIGH IMPACT
    Manufacturer
    IVOCLAR VIVADENT, INC.
    Date Cleared
    2011-02-17

    (90 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    IVOBASE HYBRID, IVOBASE HIGH IMPACT

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

    IvoBase Hybrid and IvoBase High Impact are intended for the fabrication of PMMA based acrylic dental prosthesis including but not limited to partial and full dentures.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is an FDA 510(k) clearance letter for a dental device (IvoBase Hybrid and IvoBase High Impact). It states that the device is substantially equivalent to a legally marketed predicate device.

    However, the letter does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

    Therefore, I cannot populate the requested table and provide the study details based on the provided text. The FDA clearance letter confirms regulatory approval based on substantial equivalence, but it does not include the underlying technical study data or acceptance criteria.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1