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510(k) Data Aggregation

    K Number
    K973288
    Device Name
    STABILOR HN
    Manufacturer
    DEGUSSA CORP.
    Date Cleared
    1997-11-19

    (78 days)

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

    DENTAL ALLOY BRIDGE WORK OF ANY LENGTH FULL METAL CROWN

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a dental alloy named "Stabilor HN". It does not contain any information about acceptance criteria or a study proving device performance. This letter is simply an approval to market the device based on its substantial equivalence to previously marketed devices.

    Therefore, I cannot provide the requested information as it is not present in the provided document.

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