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510(k) Data Aggregation

    K Number
    K163568
    Device Name
    SHOFU RESIN GLAZE
    Manufacturer
    Shofu Dental Corporation
    Date Cleared
    2017-08-16

    (240 days)

    Product Code
    EBD
    Regulation Number
    872.3310
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SHOFU RESIN GLAZE

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

    SHOFU RESIN GLAZE is indicated to temporarily glaze the following restoration surfaces:

    • Artificial resin teeth
    • Acrylic denture base materials
    • CAD/CAM PMMA materials
    • CAD/CAM hybrid ceramic materials
    • Indirect composite resins
    • Provisional materials
    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA regarding a dental product called "Shofu Resin Glaze". This document does not contain information about acceptance criteria for device performance, the study that proves the device meets those criteria, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or ground truth establishment.

    Therefore, I cannot provide the requested information based on the given text. This document is a regulatory clearance letter, not a clinical study report or a technical performance evaluation.

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