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510(k) Data Aggregation

    K Number
    K032416
    Device Name
    VINTAGE PRESS, VINTAGE LF, VINTAGE LF STAIN
    Manufacturer
    SHOFU DENTAL CORP.
    Date Cleared
    2004-02-05

    (184 days)

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

    Vintage Press, Vintage LF and Vintage LF Stain are dental porcelain system used for fabricating restorations (all ceramic crown and/or metal ceramic crown), build up on a ceramic substructure and/or on a metal substructure .

    Device Description

    Vintage Press, Vintage LF, Vintage LF Stain Dental Ceramic

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a dental ceramic product. It is a regulatory approval document and does not contain information about acceptance criteria or performance studies for an AI/ML powered device. Therefore, I cannot provide the requested information.

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