BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HIOSSEN, INC.

    Reg #: 3017450159 · FEI: 3017450159 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    49
    Establishment Types
    1
    Classifications
    6

    Registration Details

    Registration Name
    HIOSSEN, INC.
    Registration Number
    3017450159
    FEI Number
    3017450159
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    56-58A East Bridge Street
    City
    Morrisville
    State
    PA
    ZIP
    19067
    Country
    US

    Regulatory Submissions

    510(k) Number
    K233389

    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
    Abutment, Implant, Dental, Endosseous NHA
    Material, Tooth Shade, Resin EBF
    Resin, Denture, Relining, Repairing, Rebasing EBI
    Powder, Porcelain EIH
    Accessories, Implant, Dental, Endosseous NDP
    Positioner, Tooth, Preformed KMY

    Proprietary Names

    EK Digital Abutments Smartfit Provisional Denture Smartfit Try In Hybrid Denture ET SMARTFit Abutment Smartfit Final Hybrid Denture Bite Impression Coping Driver 3D LAB ANALOG ET Fixture Lab Analog ONE GUIDE SURGICAL TEMPLATE ET Fixture Transfer Impression Coping Hiossen Ti Abutment Screw ET Rigid Burn-out Cylinder Esthetic Low Pick-up Impression Coping ET Bite Index Esthetic Low Transfer Impression Coping Hiossen EbonyGold Abutment Screw ET Pick-up Guide Pin ET Fixture Pick-up Impression Coping Esthetic Low Lab Analog Fixture Lab Analog ET Digital Lab Analog ET Multi Digital Lab Analog ET Scan Post - Cerec Laboratory Waxing Screw Esthetic Low Polishing Protector Esthetic Low Pick-up Impression Coping Guide Pin ET Digital Lab Analog Screw Bushing Plate EK Scanbody EK Bite Impression Coping ET Scan Body EK Lab Analog EK Digital Lab Analog Convertible Pick-Up Guide Pin Convertible Transfer Impression Coping Convertible Lab Analog ET Bite Impression Coping Multi Scan Body Rigid Lab Analog Convertible Pick-Up Impression Coping O-ring Lab Analog EK Transfer Impression Coping EK Pick Up Impression Coping Stackable Guide ET Rigid Impression Coping Convertible Polishing Protector Fixture Pick-up Impression Coping Tooth Positioner

    Establishment Types

    Manufacture Medical Device