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510(k) Data Aggregation

    K Number
    K162261
    Device Name
    CERAMAGE UP
    Manufacturer
    SHOFU DENTAL CORPORATION
    Date Cleared
    2017-01-11

    (153 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    • Fabrication of permanent & temporary indirect restorations
    • Crowns & Bridges for anterior and posterior restorations
    • Jacket crowns for anterior and posterior restorations
    • Inlays & Onlays
    • Laminate veneers
    • Implant superstructures
    • Intraoral & extraoral repairs of indirect restorations
    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA regarding a dental device called "Ceramage Up". This document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement for AI/device validation. It solely confirms the substantial equivalence of the "Ceramage Up" device to legally marketed predicate devices for its stated indications for use.

    Therefore, I cannot provide the requested information based on this document. The questions you've asked are typically relevant for AI/machine learning medical devices, which require specific studies to prove their performance. This document is for a dental material (Tooth Shade Resin Material), not an AI device.

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