LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K092496
    Device Name
    COPRAN ZR/ORIGIN YZ
    Manufacturer
    WHITE PEAKS DENTAL SYSTEMS GMBH & CO. KG
    Date Cleared
    2009-09-18

    (35 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K073108
    Why did this record match?
    Device Name :

    COPRAN ZR/ORIGIN YZ

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

    Copran Zr/ Origin YZ Zirconia blanks are presintered blanks for CAD CAM or manual milling, made from biocompatible, tetragonal and polycrystalline zirconiumdioxyde. Milling blanks designed for:

    • Crown frameworks in the anterior and posterior areas
    • Bridge frameworks in the anterior and posterior areas
    • Primary conical crowns and telescopic crowns
    • Cantilevered bridges with a max. of one pontic having a premolar width
    • Inlays, Onlays, Veneers
    Device Description

    Copran Zr/ Origin YZ Zirconia blanks are presintered blanks for CAD CAM or manual milling, made from biocompatible, tetragonal and polycrystalline zirconiumdioxyde. The devices are sold in different shapes, figures and dimensions to match the specification of the different CAD/CAM milling machines used to generate the final restaurations. This may be shapes like disks, cubes, bars and cylinders.

    AI/ML Overview

    The provided text is related to a 510(k) premarket notification for a dental device (Copran Zr/Origin YZ Zirconia blanks) and does not contain information about the acceptance criteria or a study proving the device meets those criteria. The document is primarily a summary of the 510(k) submission, including device information, indications for use, and an FDA letter confirming substantial equivalence to a predicate device.

    Therefore, I cannot provide the requested information based on the given text. The text does not include:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes or data provenance for any test set.
    3. Information about experts used to establish ground truth.
    4. Adjudication methods.
    5. Details on an MRMC comparative effectiveness study or effect sizes.
    6. Results of a standalone algorithm performance study.
    7. The type of ground truth used.
    8. Sample size for a training set.
    9. How ground truth for a training set was established.

    This document focuses on the regulatory submission process and the determination of substantial equivalence, not the detailed technical performance or validation studies that would contain the requested information.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1