BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    Neoss Individual Prosthetics

    Reg #: 3014615056 · FEI: 3014615056 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ARC SOLUTIONS AB
    Registration Number
    3014615056
    FEI Number
    3014615056
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Florettgatan 35, Helsingborg
    City
    Helsingborg Skane
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K211396

    Owner / Operator

    Firm Name
    ARC Solutions AB
    Operator Number
    10057832
    Address
    Florettgatan 35, Helsingborg
    City
    Helsingborg
    State
    Skane
    Postal Code
    25467
    Country
    SE
    Correspondent
    Kristofer Frick

    US Agent

    Business Name
    M Squared Associates/a PPG Company
    Contact Name
    Cherita James
    Address
    1129 20th St NW, Suite 600
    City
    Washington
    State
    DC
    ZIP
    20036
    Country
    US
    Email
    [email protected]
    Phone
    347 9540624

    Products

    Device Name Product Code
    Abutment, Implant, Dental, Endosseous NHA

    Proprietary Names

    Neoss Individual Prosthetics Neoss Individual Abutment Ti SSC, Neoss Individual Abutment Ti ASC, Bridge Ti, Bar Ti, Dolder Bar Ti

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)