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

    Neodent Implant System-Helix NGM Compact Surgical Kit Cases

    K Number: K214051 · Decision Apr 13, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    266
    Registration Numbers
    266
    Same Product Code
    279
    Applicant Total
    11
    Review Days
    107

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    Basic Information

    Device Name
    Neodent Implant System-Helix NGM Compact Surgical Kit Cases
    K Number
    K214051
    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 Indústria e Comércio de Materiais Dentários S.A.
    Date Received
    December 27, 2021
    Decision Date
    April 13, 2022
    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 Indústria e Comércio de Materiais Dentários S.A.

    K Number Device Name
    K253922 Neodent Scannable Healing Abutment
    K252727 Neodent InLab Validated Workflow
    K252090 Pterygoid Indication for GM Helix Implants
    K250271 Neodent Implant System - Zirconia Implant System
    K241492 Guided Surgery Kit Cases
    K233857 Neodent Implant System – Custom Abutments
    K231803 Neodent Implant System - Zirconia Implant System
    K232099 Neodent Implant System - GM Zygomatic Implant System
    K230804 Complement Kit Cases
    K203309 NUVO CF Implant System
    Search all 11 clearances from JJGC Indústria e Comércio de Materiais Dentários S.A. →