LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K132102
    Device Name
    BECE CAD ZIRKON HT+
    Manufacturer
    BEGO BREMER GOLDSCHLAEGEREI WILH. HERBST GMBH & CO
    Date Cleared
    2013-11-12

    (127 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K011394
    Why did this record match?
    Device Name :

    BECE CAD ZIRKON HT+

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

    BeCe CAD Zirkon HT+ is indicated for the fabrication of single crowns and bridgework.

    • Fully anatomical crowns and bridges -
    • Partial-veneered and fully veneered crowns and bridges -
    • Dentine core crowns and bridges -
    • Maryland bridges -
    • Telescopic crowns (primary part) -
    Device Description

    BeCe CAD Zirkon HT+ consists of yttria stabilized zirconia and is suitable for the fabrication of dental ceramic restorations. BeCe CAD Zirkon HT+ is available as milling blank and is processed by milling technique.

    AI/ML Overview

    The provided text describes a dental product, "BeCe CAD Zirkon HT+", and its substantial equivalence to a predicate device based on meeting certain industry standards. However, it does not contain information about acceptance criteria for an AI/ML device, a study proving an AI/ML device meets acceptance criteria, sample sizes for test or training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.

    The document is a 510(k) summary for a dental material (zirconia powder), not an AI/ML device. Therefore, it does not address any of the specific points requested in the prompt regarding AI/ML device evaluation.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1