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510(k) Data Aggregation

    K Number
    K051462
    Device Name
    MODIFICATION TO: CERCON BASE
    Manufacturer
    DENTSPLY INTL.
    Date Cleared
    2005-06-24

    (21 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Type
    Special
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K013230
    Why did this record match?
    Device Name :

    MODIFICATION TO: CERCON BASE

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

    CERCON® BASE is indicated for crowns, multi-unit bridges, and inlay bridges. Applications include both anterior and posterior regions.

    Device Description

    CERCON® BASE is a dense ceramic composed of partially sintered yttria stabilized zirconia powder (1-TZP). It is processed in the dental laboratory by machining from a partially sintered 1-TZP blank which is then sintered to near full density and finally veneered with a dental veneering ceramic. It is designated as a substructure (framework) for single tooth or bridge type restorations. CERCON® BASE is similar to other 1-TZP products currently in the market.

    AI/ML Overview

    The provided text is a 510(k) summary for the CERCON® BASE dental material, which is a partially sintered yttria-stabilized zirconia powder used for crown and bridge restorations. It describes the device, its intended use, and technological characteristics compared to a predicate device.

    However, the document does not contain any information about acceptance criteria, a study proving the device meets these criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

    Therefore, I cannot provide the requested information. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device based on material composition and intended use, rather than specific performance metrics or clinical study results as you've requested.

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