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510(k) Data Aggregation

    K Number
    K113426
    Device Name
    VERACIA SA
    Manufacturer
    SHOFU DENTAL CORPORATION
    Date Cleared
    2012-02-08

    (82 days)

    Product Code
    ELM
    Regulation Number
    872.3590
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    VERACIA SA

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

    Used as artificial teeth to produce partial and full dentures.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA for a dental device called "Veracia SA," which is described as a preformed plastic denture tooth.

    This document does not contain information about acceptance criteria or a study proving the device meets those criteria, as it pertains to AI/algorithm performance. It is a regulatory approval for a physical dental product, not a software or AI-powered medical device.

    Therefore, I cannot provide the requested information for an AI/algorithm-based device from this document.

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