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510(k) Data Aggregation

    K Number
    K023198
    Device Name
    CERANUM 90
    Manufacturer
    SB LUCIUS, INC.
    Date Cleared
    2002-11-01

    (37 days)

    Product Code
    EJT
    Regulation Number
    872.3060
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K001196
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This is a yellow ceramic alloy for single units, implants prosthetics, single & 3/4 crowns, and short span bridges.

    Device Description

    CERANUM 90 is a High Noble, Micro-fine, Yellow, Gold based alloy to be used for inlays, onlays, single crowns, bridge, implant superstructures and substrate for medium expansion with lower fusing porcelains and indirect restorative composites. CERANUM 90 is a high gold ceramic alloy, which heightens the porcelain esthetics of the restoration and provides strength. durability and color of gold.

    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the CERANUM 90 device, structured to answer your specific questions.

    In this 510(k) summary, the device is a dental casting alloy, and the "study" is a comparison to a legally marketed predicate device, not a typical diagnostic or AI-based study. As such, some of your requested categories (like MRMC studies, training set, or expert adjudication for image ground truth) are not applicable.

    Acceptance Criteria and Device Performance for CERANUM 90

    1. Table of Acceptance Criteria and Reported Device Performance

    PropertyAcceptance Criteria (Predicate: Jel Bios 90)Reported Device Performance (Ceranum 90)
    Composition (Weight %)
    Au90.0090.00
    Pt7.404.00
    Pd-11.95
    Ag1.00.05
    Cu-0.2
    Sn-0.40
    Fe
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