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    K Number
    K200470
    Device Name
    Shofu Block HC Hard
    Manufacturer
    Shofu Dental Corporation
    Date Cleared
    2021-02-05

    (345 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Shofu Block HC Hard

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

    For fabrication of inlays / onlays, laminate veneers, anterior and posterior full crown restorations and implant supported restorations, using a dental CAD / CAM system.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a dental material (Shofu Block HC Hard), not an AI/ML device. Therefore, the requested information about acceptance criteria and studies proving the device meets them, particularly concerning AI/ML performance metrics, ground truth, sample sizes, and expert adjudication, is not applicable to this document.

    The document discusses the regulatory clearance process for a tooth shade resin material under the name "Shofu Block HC Hard" and confirms its substantial equivalence to predicate devices. It outlines general regulatory requirements for medical devices but does not include any performance data or study details that would typically be associated with AI/ML device evaluations.

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