BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇧🇷 Brazil

    Neodent Implant System - GM Helix Implants 7.0

    K Number: K201225 · Decision Sep 4, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    324
    Registration Numbers
    324
    Same Product Code
    1545
    Applicant Total
    28
    Review Days
    121

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    Basic Information

    Device Name
    Neodent Implant System - GM Helix Implants 7.0
    K Number
    K201225
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Jjgc Industria E Comercio DE Materiais Dentarios S.A.
    Date Received
    May 6, 2020
    Decision Date
    September 4, 2020
    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 Jjgc Industria E Comercio DE Materiais Dentarios S.A.

    K Number Device Name
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    K210336 Neodent Implant System - Zirconia Implant System
    K203542 Neodent Implant System - Mini Abutment 60°
    K203382 Neodent Implant System-Easy Pack
    K203618 Neodent EasyGuide Kit Cases
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    Search all 28 clearances from Jjgc Industria E Comercio DE Materiais Dentarios S.A. →