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510(k) Data Aggregation

    K Number
    K052463
    Device Name
    PROMETAL HN86
    Manufacturer
    PROMETAL TECHNOLOGIES
    Date Cleared
    2005-10-14

    (36 days)

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

    PROMETAL HN86

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

    HIGH NOBLE DENTAL ALLOY FOR THE FABRICATION OF SINGLE CROWNS, BRIDGES, INLAYS AND ONLAYS.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a dental alloy named "PROMETAL HN86." This document grants market clearance based on substantial equivalence to a predicate device. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or clinical effectiveness studies (like MRMC or standalone performance).

    Therefore, I cannot provide the requested information about acceptance criteria and the study that proves the device meets them based on the given text. The document is primarily a regulatory clearance notification.

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