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510(k) Data Aggregation

    K Number
    K033553
    Device Name
    PFZ PORCELAIN SYSTEM
    Manufacturer
    DENTSPLY INTL.
    Date Cleared
    2003-12-02

    (22 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Type
    Special
    Panel
    Dental
    Reference & Predicate Devices
    K022796
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Designed for use on zirconia (zirconium oxide) in single tooth or bridge type restorations. Applications include both anterior and posterior locations.

    Device Description

    The PFZ™ PORCELAIN SYSTEM is a dental ceramic veneering material for fixed prosthodontics devices that include both anterior and posterior crowns/bridges.

    The PFZ™ PORCELAIN SYSTEM consists of a Dentin/Transparent/Incisal porcelain, a Liner/Opaque porcelain, a Shoulder porcelain, and a Correction/Glaze/Stain porcelain in tooth colored shades.

    AI/ML Overview

    The provided document is a 510(k) summary for the PFZ™ PORCELAIN SYSTEM, a dental ceramic veneering device. It does not describe any acceptance criteria or studies related to artificial intelligence (AI) or machine learning (ML) models.

    Therefore, I cannot answer the questions regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details as they pertain to an AI device.

    The document focuses on demonstrating substantial equivalence to a predicate device (Cercon® Ceram S Porcelains K022796) for a traditional dental material. The stated evidence for this equivalence is based on:

    • Prior use of components in legally marketed devices.
    • Similarity in formulations.
    • Biocompatibility testing (cytotoxicity).
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