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510(k) Data Aggregation

    K Number
    K021965
    Device Name
    CHROLOY SOLDER
    Manufacturer
    NEIRYNCK & VOGT NV
    Date Cleared
    2002-07-26

    (39 days)

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

    CHROLOY SOLDER

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

    Chroloy Solder is intended to be used by dentists and dental laboratories for the as a solder for Chroloy Partial Denture alloy. It is used in the fabrication of removable partial dentures.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided document, I cannot answer the question. The document is a 510(k) clearance letter for a dental solder ("Chroloy Solder") and primarily focuses on its substantial equivalence to predicate devices and regulatory compliance. It does not provide information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment as would be relevant for a medical device with diagnostic or AI components.

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