BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    Noris Medical MBI-2mm Dental Implant System

    K Number: K162308 · Decision Mar 17, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    324
    Registration Numbers
    324
    Same Product Code
    1545
    Applicant Total
    8
    Review Days
    212

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    Basic Information

    Device Name
    Noris Medical MBI-2mm Dental Implant System
    K Number
    K162308
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Noris Medical , Ltd.
    Date Received
    August 17, 2016
    Decision Date
    March 17, 2017
    Product Code
    DZE
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DZE Implant, Endosseous, Root-Form

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    Other Clearances by Noris Medical , Ltd.

    K Number Device Name
    K241462 LONGY Implant and LONGY-N Implant
    K240202 Conical Platform Dental Implants System
    K210852 Noris Medical Dental Implants System - Cortical
    K210356 Noris Medical Dental Implants System
    K153043 Noris Medical MBI Dental Implant System
    K151909 Noris Medical Zygomatic Dental Implant System
    K140440 NORIS MEDICAL DENTAL IMPLANTS SYSTEM