BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    NEW HANARO KIT (HKA)

    Reg #: 3003394081 · FEI: 3003394081 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    69
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    OSSTEM IMPLANT CO., LTD.
    Registration Number
    3003394081
    FEI Number
    3003394081
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    66-16, Bansong-ro 513beon-gil,
    City
    Haeundae-gu Busan
    Country
    KR

    Owner / Operator

    Firm Name
    OSSTEM IMPLANT CO LTD
    Operator Number
    9062743
    Address
    66-16, Bansong-ro 513beon-gil,
    City
    Haeundae-gu
    State
    Busan
    Postal Code
    48002
    Country
    KR

    US Agent

    Business Name
    HIOSSEN, Inc.
    Contact Name
    Mateusz Leszczak
    Address
    85 Ben Fairless Drive
    City
    Fairless Hills
    State
    PA
    ZIP
    19030
    Country
    US
    Email
    [email protected]
    Phone
    201 2660657

    Products

    Device Name Product Code
    Fixture Mount Kit NYE

    Proprietary Names

    NEW HANARO KIT (HKA) HANARO KIT (HSK) Osstem Basic Instrument Kit Smart builder Kit Dr.Cho's Instrument Kit Standard KIT Upper Prosthetic Kit Case Middle NEW Prosthetic KIT ESR Full KIT Prosthetic Kit Case Upper 122 TAPER KIT CASE MIDDLE PLAT OneGuide KIT Split Kit - Offset Ultra KIT SmartGuide KIT EFR KIT Parallel Guide Advanced KIT Taper Ultra KIT Positioning Guide FULL Kit Positioning Guide Kit 122 Taper KIT Prosthetic Kit Case Low Split Kit - Straight CUSTOM KIT Standard KIT lower ESSET KIT Osteo Kit Crestal Approach Sinus (CAS) Kit ESR FULL KIT COMPONENT IM-Cure Kit Set ESR KIT Taper Kit Case OneMS KIT 122 Taper Full Kit EFR Full KIT OneCAS KIT Lateral Approach Sinus (LAS) KIT OneGuide KIT CASE UPPER PLATE Denture 4U Kit HM KIT (HIOSSEN MS KIT) Sinus Lift Kit Taper KIT OssBuilder Kit Osteotome Kit GBR Kit Prosthetic Simple KIT (OPSK) 123 Straight Full KIT Lateral Approach Sinus (LAS) KIT PLUS One Day KIT ORP KIT Ortho KIT 485 Kit One485 KIT OsstemGuide KIT EM Kit Bone Compaction KIT Sinus KIT OneGuide Training KIT 123 KIT Assist KIT Selection KIT Bone Screw KIT OnePositioning KIT Bone Spreader KIT OneGuide Accessory KIT ADVANCED KIT (HAK) SURGICAL KIT FOR GS Simple Kit OneArch KIT

    Establishment Types

    Manufacture Medical Device