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510(k) Data Aggregation

    K Number
    K972118
    Device Name
    VERA PDN
    Manufacturer
    AALBA DENT, INC.
    Date Cleared
    1997-08-15

    (71 days)

    Product Code
    EJH
    Regulation Number
    872.3710
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    VERA PDN

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

    VERA PDN, a cobalt-chromium based alloy in nugget form, is intended for use in the fabrication of custom-made removable denture appliances.

    Device Description

    VERA PDN, a cobalt-chromium based alloy in nugget form

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding a dental alloy named Vera PDN. This document primarily concerns the regulatory approval for marketing the device based on its substantial equivalence to previously marketed devices. It does not contain information about specific acceptance criteria or the details of a study proving the device meets such criteria.

    Therefore, I cannot provide the requested information. The document is a regulatory approval letter, not a study report.

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