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510(k) Data Aggregation

    K Number
    K034049
    Device Name
    HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, B AND A; BIO HERANORM
    Manufacturer
    HERAEUS KULZER GMBH
    Date Cleared
    2004-03-01

    (62 days)

    Product Code
    EJT
    Regulation Number
    872.3060
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, B AND A; BIO HERANORM

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

    Reconstruction of porcelain to metal dental restorations/reconstruction of dental restorations.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) premarket notification letter from the FDA to Heraeus Kulzer GmbH & Company KG, confirming that their dental alloys are substantially equivalent to legally marketed predicate devices for the indicated uses. It outlines regulatory requirements and allows the company to market their devices.

    Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or details about the training set.

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