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510(k) Data Aggregation

    K Number
    K040180
    Device Name
    CONTINUM V
    Manufacturer
    AALBA DENT, INC.
    Date Cleared
    2004-03-04

    (37 days)

    Product Code
    EJH
    Regulation Number
    872.3710
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This device is a non precious, nickel-chromium-molybdenum-berylium based ceramic casing alloy for use in the construction of cast ceramic bonded crown and bridge prosthetic devices.

    Device Description

    This device is a non precious, nickel-chromium-molybdenum-berylium based ceramic casing alloy for use in the construction of cast ceramic bonded crown and bridge prosthetic devices.

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications for a device. The document is an FDA 510(k) clearance letter for a dental alloy named "Continum™ V," confirming its substantial equivalence to a legally marketed predicate device. It addresses regulatory information, marketing authorization, and general compliance requirements, but it does not include performance studies or validation data.

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