BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HIOSSEN INC.

    Reg #: 3007135442 · FEI: 3007135442 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    85
    Establishment Types
    3
    Classifications
    4

    Registration Details

    Registration Name
    HIOSSEN INC.
    Registration Number
    3007135442
    FEI Number
    3007135442
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    85 BEN FAIRLESS DR
    City
    Fairless Hills
    State
    PA
    ZIP
    19030
    Country
    US

    Regulatory Submissions

    510(k) Number
    K110308

    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
    Implant, Endosseous, Root-Form DZE
    Accessories, Implant, Dental, Endosseous NDP
    Bone Grafting Material, Animal Source NPM

    Proprietary Names

    ET Ziocera Angled Abutments ET Gold Cast Abutments EM Provisional EK D3.3 and Ultra Wide Dental Implants ETII SA FIXTURE SYSTEM ET Freeform ST Abutments ET Quick Temporary Abutments ET Multi Abutments ET Rigid Abutments ET Ziocera Abutments ET SMARTFit Abutment 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 EK Dental Implants and Abutments ET Esthetic Low Plastic Cylinder ET III Nano-HA Fixture System ET III Fixture Regular NH ET III Fixture Mini NH ET Transfer Abutments ET Combination Angled Cylinder ET Multi-NP Cast Cylinder ET Convertible Angled Cylinder ET Temporary Abutments ET Stud Abutments ET Esthetic Low Temporary Cylinder ET Multi-Angled Abutments ET Angled Abutments HIOSSEN Pre-milled Abutment HIOSSEN IMPLANT SYSTEM ET III Fixture Mini SA ET III Fixture Regular SA EK Digital Abutments ET Esthetic Low Gold Cylinder ET NP-Cast Abutments EK Multi Angled 30 Degree Abutment ET Multi Angled Abutment A-Graft EM SA Implant System ET Abutment System ET IV SA Dental Implants ET IV NH Dental Implants ET Hybrid Abutment ETIII SA Fixture System (D3.2) ET III SA Fixture

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198