BEUDAMED
    FDA Registration Active 🇧🇷 Brazil

    Neodent Implant System - GM Helix 7

    Reg #: 3008261720 · FEI: 3008261720 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    JJGC Industria e Comercio de Materiais Dentarios SA
    Registration Number
    3008261720
    FEI Number
    3008261720
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Avenida Juscelino Kubitschek de Olivera, 3291
    City
    Curitiba Parana
    Country
    BR

    Regulatory Submissions

    510(k) Number
    K201225

    Owner / Operator

    Firm Name
    INSTITUT STRAUMANN AG
    Operator Number
    9005052
    Address
    PETER MERIAN-WEG 12
    City
    BASEL
    State
    CH-NOTA
    Postal Code
    CH-4002
    Country
    CH

    US Agent

    Business Name
    Straumann USA, LLC
    Contact Name
    Jennifer Jackson
    Address
    60 Minuteman Road
    City
    Andover
    State
    MA
    ZIP
    01810
    Country
    US
    Email
    [email protected]
    Phone
    978 7472509

    Products

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

    Proprietary Names

    Neodent Implant System - GM Helix 7

    Establishment Types

    Manufacture Medical Device