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510(k) Data Aggregation

    K Number
    K974358
    Device Name
    FRIALIT -2 SCREW
    Manufacturer
    FRIATEC AG
    Date Cleared
    1998-02-10

    (83 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    K031674
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    FRIALIT-2 implants are indicated for single tooth replacement, as immediate abutments on long span to bridgework, as distal abutments on free-end edentulous areas to be restored with fixed bridgework, to support overdentures in totally or partially edentulous bridget.orn, to outments supporting a full arch fixed prosthesis in the totally edentulous mandibite or maxila.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a dental implant device, Frialit-2 Screw. It states the device is substantially equivalent to a legally marketed predicate device but does not contain information about acceptance criteria, study details, or device performance data. Therefore, I cannot extract the requested information from the provided text.

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