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510(k) Data Aggregation

    K Number
    K972594
    Device Name
    METALPRIMER II
    Manufacturer
    GC AMERICA, INC.
    Date Cleared
    1997-08-26

    (46 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    METALPRIMER II

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

    Metalprimer II is a metal surface treatment material which provides a bond between the resin and metal in fabriacting dental appliances such as bonding opaque material to metal framework for hard resin veneer crowns, bonding denture base resin to metal base, clasp, attachment, repair of denture and bonding orthodontic resin to metal orthodontic bracket and wire.

    Device Description

    Metalprimer II is a metal surface treatment material.

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) clearance letter from the FDA for a device called "Metalprimer II," indicating it has been found substantially equivalent to a predicate device. It specifies general controls, classification, and indications for use, but does not detail any performance studies, acceptance criteria, or their fulfillment.

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