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510(k) Data Aggregation

    K Number
    K170050
    Device Name
    Z-CAD smile
    Manufacturer
    Metoxit AG
    Date Cleared
    2018-08-23

    (595 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K150196,K152118,K152383
    Why did this record match?
    Reference Devices :

    K150196, K152118

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

    METOXIT Z-CAD® smile blanks are indicated for the preparation of full ceramic crowns, inlays, veneers and 3 unit bridges in the anterior area. All white Z-CAD® smile blanks are indicated to be coloured with Z-CAD® Liquid smile-TC.

    The Z-CAD® Liquid smile-TC will be used to dye white pre-sintered zirconia restorations milled from Z-CAD® smile blanks in the dental field.

    Device Description

    Z-CAD® smile ceramic blanks are indicated for the production of dental-prosthetic restorations. The blanks named above can be machined with CAM, CAD/CAM or copy milling systems commonly used in dental medical technology to produce dental-prosthetic restorations made from zirconium oxide. This material offers excellent properties with regards to bio-compatibility, stability and aesthetics, which make it the material of choice for the production of restorations for dental crowns, inlays, onlays, veneers, and up to three unit bridges, which in turn combine the advantages of conventional casting technology and full ceramics. Dental technicians are therefore in a position to offer patients the extra added value when finishing the prosthesis.

    Metoxit Z-CAD® smile Blanks also includes Z-CAD® Liquids smile-TC. Z-CAD® Liquids smile-TC are ready for use water-based products, which are applied to the milled restauration prior to sintering to achieve individual shades. These liquids are specifically formulated for the dyeing of Z-CAD® smile blanks from Metoxit AG.

    AI/ML Overview

    The provided text describes the 510(k) summary for the Z-CAD® Smile device, which is a dental ceramic blank used for prosthetic restorations. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a comprehensive study report with detailed acceptance criteria and performance data in a traditional clinical trial format.

    However, I can extract the relevant information regarding performance testing and acceptance criteria for the physical properties of the device as presented, and address the other points based on the available text.

    Acceptance Criteria and Device Performance Study for Z-CAD® Smile

    The Z-CAD® Smile device is a dental ceramic blank. The performance data presented focuses on physical and biocompatibility properties, demonstrating its safety and effectiveness by comparison to a predicate device and established standards.

    1. Table of Acceptance Criteria and Reported Device Performance (Physical Properties):

    Physical PropertyUnitsZ-CAD® Smile Acceptance CriteriaReported Z-CAD® Smile PerformancePrimary Predicate Device PerformanceTesting Method
    Bending strength (biaxial)MPa$\ge 500$610> 500ASTM C1161
    Solubility (acetic acid)µg/cm$^2$$\le 100$$\le 50$
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