BEUDAMED
    FDA Registration Active 🇺🇸 United States

    EM SA Implant System

    Reg #: 3007135442 · FEI: 3007135442 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    HIOSSEN INC.
    Registration Number
    3007135442
    FEI Number
    3007135442
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    85 BEN FAIRLESS DR
    City
    Fairless Hills
    State
    PA
    ZIP
    19030
    Country
    US

    Regulatory Submissions

    510(k) Number
    K191201

    Owner / Operator

    Firm Name
    Hiossen Inc.
    Operator Number
    10026425
    Address
    85 Ben Fairless Dr.
    City
    Fairless Hills
    State
    PA
    Postal Code
    19030
    Country
    US

    Products

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

    Proprietary Names

    EM SA Implant System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device