BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PRIMUS Implant System

    Reg #: 3022316560 · FEI: 3022316560 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    INOSYS, INC.
    Registration Number
    3022316560
    FEI Number
    3022316560
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    545 W 45th St Fl 11
    City
    New York
    State
    NY
    ZIP
    10036
    Country
    US

    Regulatory Submissions

    510(k) Number
    K171297

    Owner / Operator

    Firm Name
    INOSYS, INC.
    Operator Number
    10084921
    Address
    545 W 45th St Fl 11, New York, NY 10036
    City
    New York
    State
    NY
    Postal Code
    10036
    Country
    US
    Correspondent
    Chang Bin Lee

    Products

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

    Proprietary Names

    PRIMUS Implant System Cemented Abutment (HEX) Cemented Abutment (NON-HEX) Healing Abutment Closing Screw

    Establishment Types

    Repack or Relabel Medical Device