BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Duranext Duo

    Reg #: 3017125693 · FEI: 3017125693 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ZENTEK MEDICAL LLC
    Registration Number
    3017125693
    FEI Number
    3017125693
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    81 Pension Road Suite 116
    City
    Manalapan
    State
    NJ
    ZIP
    07726
    Country
    US

    Regulatory Submissions

    510(k) Number
    K162853

    Owner / Operator

    Firm Name
    Zentek Medical LLC
    Operator Number
    10076447
    Address
    81 Pension Road Suite 116
    City
    Manalapan
    State
    NJ
    Postal Code
    07726
    Country
    US
    Correspondent
    Michael Vinnik

    Products

    Device Name Product Code
    Abutment, Implant, Dental, Endosseous NHA
    Implant, Endosseous, Root-Form DZE

    Proprietary Names

    Duranext Duo Zentek Dentlot

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility