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510(k) Data Aggregation

    K Number
    K083201
    Device Name
    ZMATCH BLOCK
    Manufacturer
    DENTAIM CO., LTD.
    Date Cleared
    2009-01-26

    (88 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K062695,K013230
    Predicate For
    K093571
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Zmatch® Block is intended for CAD/CAM fabrication of all-ceramic dental restorations. The Zmatch® Block is used for the manufacturing of inlays, onlays, veneers, crowns and bridges.

    Device Description

    Zmatch® Block is a pre-formed machineable dental blank composed of zirconium oxide Zmatch® Block is available in partially-sintered Zmatch® Block is available in different shapes, and dimensions Zmatch® Block has two models that are Atype model and B-type model The difference between A-type and B-type is material composition. Zmatch® Block is a pre-formed ceramic dental blank intended for CAD/CAM fabrication of zirconia frameworks for all-ceramic dental restorations Zmatch® Block is designed for manufacturing ceramic dental restorations such as single crowns or bridgeworks The blank is machined by the customers/dental laboratories on their milling centers or similar equipment using CAD/CAM techniques for design.

    AI/ML Overview

    This 510(k) summary describes a dental device, the Zmatch® Block, and asserts its substantial equivalence to predicate devices. However, it does not contain the information required to answer your specific questions regarding acceptance criteria and a study proving the device meets them.

    Specifically, the document does not include:

    • A table of acceptance criteria and reported device performance.
    • Information on a test set (sample size, data provenance).
    • Details about experts for ground truth or adjudication methods.
    • A multi-reader multi-case (MRMC) comparative effectiveness study.
    • A standalone algorithm performance study.
    • The type of ground truth used.
    • Information on a training set (sample size, ground truth establishment).

    The purpose of this document is to demonstrate that the Zmatch® Block, a pre-formed machineable dental blank, is substantially equivalent to other legally marketed predicate devices (Sagemax Z-Blank, Cercon Base, LAVA Zirconia). This equivalence is based on similar intended use, material composition, biocompatibility, and biomechanical strength and properties, rather than performance metrics from a formal study against defined acceptance criteria.

    Therefore, I cannot provide the requested information from the provided text.

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