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    K Number
    K152383
    Device Name
    Ceramill Zolid FX
    Manufacturer
    Emergo Europe Consulting
    Date Cleared
    2015-09-21

    (28 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K063511
    Why did this record match?
    Device Name :

    Ceramill Zolid FX

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

    "Ceramill Zold FX" preshade are blanks made of zirconium oxide (ZrO2) for type II, class 5 dental applications in accordance with DIN EN ISO 6872. They are used for manufacturing permanent and removable prosthetic restorations (e.g., crowns and three-unit bridges to the molar region) using CNC milling machines (e.g., Ceramill Motion).

    Device Description

    Amann Girrbach AG "Ceramill Zolid FX" is an all-ceramic core dental material made of Yttria-Stabilized Zirconium Oxide (zirconia, YSZ). It is provided as a disk shape (U-shape). CAD/CAM fabrication of core material can then be used to produce copings and substrates for fixed all ceramic dental restorations above the gum line. The material is used for the manufacturing of permanent and removable prosthetic restorations (e.g. crowns and three-unit bridges to the molar region). The material is then fired in an oven to harden the ZrO2. The milling and final oven hardening is completed by the customer (the dental technician).

    AI/ML Overview

    The document provided describes the submission of a medical device (Ceramill Zolid FX) for FDA clearance, demonstrating its substantial equivalence to a predicate device (Ceramill ZI blanks). The information provided focuses on non-clinical performance data and does not contain details about studies involving human readers or AI assistance. Therefore, some of the requested information, particularly related to human reader studies, AI assistance, and large-scale data sets, is not applicable or available in this document.

    Here's an analysis based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria for "Ceramill Zolid FX" are based on conformance to applicable national and international standards, primarily ANSI ADA Specification No. 69:2010 (Dental Ceramic) and ISO 6872:2008 (Dentistry – Ceramic Materials), as well as internal specifications.

    Test / Performance MetricAcceptance Criteria (Standard / Predicate)Reported Device Performance (Ceramill Zolid FX)
    Material Composition (wt%)Zirconia (ZrO2 + HfO2 + Y2O3 > 99.0%) (Predicate)Zirconia (ZrO2 + HfO2 + Y2O3 ≥ 99.0%)
    Y2O34.5 - 5.6 (Predicate)9.15 - 9.55
    Al2O3500 MPa / Meets ISO 13356 & ISO 6872 (Note: Lower than predicate, but still meets standard for its limited indications)
    Weibull Modulus10.63 (Predicate) / Meets ISO 13356 & ISO 68729.54 / Meets ISO 13356 & ISO 6872
    Hardness (Vicker's Hardness)1300 ± 200 HV10 (Predicate) / Meets internal specifications1300 ± 200 HV10 / Meets internal specifications
    Coefficient of Thermal Expansion10.4 ± 0.5 *10-6/K (Predicate) / Meets ISO 9396 & ISO 687210.1 ± 0.5 *10-6/K / Meets ISO 9396 & ISO 6872
    Modulus of Elasticity>200 GPa (Predicate) / Meets internal specifications>200 GPa / Meets internal specifications
    Radioactivity (raw material)
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