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510(k) Data Aggregation

    K Number
    K013230
    Device Name
    CERCON BASE
    Manufacturer
    DEGUSSA - NEY DENTAL, INC.
    Date Cleared
    2001-10-25

    (28 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    K050903,K051462,K072569,K083201,K092630,K100232,K112152,K112710
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Cercon Base is a partially sintered yttria (yttrium oxide) stabilized zirconia (zirconium oxide) powder that is machined and then sintered to full density. It is designed for use as a substructure (framework) for single tooth or bridge type restorations. Applications include both anterior and posterior locations.

    Device Description

    Cercon Base is a partially sintered yttria (yttrium oxide) stabilized zirconia (zirconium oxide) powder that is machined and then sintered to full density.

    AI/ML Overview

    I am sorry, but based on the provided text, I cannot extract any information about acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) premarket notification letter from the FDA regarding a dental ceramic device named "Cercon Base." It primarily discusses the regulatory approval process, classification, and general compliance requirements for marketing the device. There is no mention of specific acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment.

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