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

    Neodent Implant System - GM Narrow Implant System

    K Number: K220251 · Decision Sep 6, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    324
    Registration Numbers
    324
    Same Product Code
    1545
    Applicant Total
    28
    Review Days
    218

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Neodent Implant System - GM Narrow Implant System
    K Number
    K220251
    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
    January 31, 2022
    Decision Date
    September 6, 2022
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (DZE), ordered by most recent decision date.

    MegaGen Zygoma Dental Implant System

    FDA 510(k)
    FDA Class 2 ·Dental

    Dental Implant System

    FDA 510(k)
    FDA Class 2 ·Dental

    INOSS System

    FDA 510(k)
    FDA Class 2 ·Dental

    Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant

    FDA 510(k)
    FDA Class 2 ·Dental

    Adin Long Dental Implant System

    FDA 510(k)
    FDA Class 2 ·Dental

    ZENEX Implant System_Short (R-System)

    FDA 510(k)
    FDA Class 2 ·Dental
    View all

    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
    K223662 Neodent Implant System - Helix Short Surgical Kit Cases
    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. →