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510(k) Data Aggregation

    K Number
    K993897
    Device Name
    CERGOGOLD
    Manufacturer
    DEGUSSA - NEY DENTAL, INC.
    Date Cleared
    2000-01-10

    (55 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    K033667
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Ceramic Core This product 1 S used in the manufacture a "all-ceramic dental restorations, The product in the form of pellets and is processed with corrently marketed fornaces

    Device Description

    The product in the form of pellets

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding a dental product named "Cergogold." It confirms substantial equivalence but does not contain information about acceptance criteria or a study proving device performance. Therefore, I cannot generate the requested information based on the provided input.

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