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

    Neodent Implant System - Helix Short Surgical Kit Cases

    K Number: K223662 · Decision Apr 20, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    266
    Registration Numbers
    266
    Same Product Code
    279
    Applicant Total
    28
    Review Days
    135

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    Basic Information

    Device Name
    Neodent Implant System - Helix Short Surgical Kit Cases
    K Number
    K223662
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6850
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Jjgc Industria E Comercio DE Materiais Dentarios S.A.
    Date Received
    December 6, 2022
    Decision Date
    April 20, 2023
    Product Code
    KCT
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

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    Other Clearances by Jjgc Industria E Comercio DE Materiais Dentarios S.A.

    K Number Device Name
    K222026 Neodent Implant System - Zirconia Implant System
    K223638 Neodent Implant System - Helix Short Implant System
    K220251 Neodent Implant System - GM Narrow Implant System
    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
    K202282 Neodent Implant System - Zirconia Implant System
    K201491 Neodent Implant System - Zirconia Implant System
    K202515 NUVO Implant System – NUVO Instrument Kit Cases
    Search all 28 clearances from Jjgc Industria E Comercio DE Materiais Dentarios S.A. →