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510(k) Data Aggregation

    K Number
    K963521
    Device Name
    IMZ TWIN PLUS - CYLINDER
    Manufacturer
    IMZ, GMBH
    Date Cleared
    1997-08-06

    (337 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    IMZ implants are indicated for single tooth replacement, as immediate abutments on long span to bridgework, as distal abutments on free-end edentulousareas to be restored with fixed bridgework, to support overdentures in totally or partially edentulous arches, and as abutments supporting a full arch fixed prosthesis in the totally edentulous mandible or maxila.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided document, there is no information available regarding the acceptance criteria for a device, the study that proves the device meets the acceptance criteria, or any of the specific details requested in your prompt (e.g., sample size, expert qualifications, adjudication method, MRMC study, standalone performance, ground truth type, training set details).

    The document is a 510(k) clearance letter from the FDA for a device called "IMZ Twin Plus - Cylinder," which are dental implants. It states that the device is substantially equivalent to legally marketed predicate devices and outlines the indications for use. However, it does not contain the detailed performance study information you are seeking.

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