BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    BIOTEM CO., LTD.

    Reg #: 3009611645 · FEI: 3009611645 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    42
    Establishment Types
    1
    Classifications
    6

    Registration Details

    Registration Name
    BIOTEM CO., LTD.
    Registration Number
    3009611645
    FEI Number
    3009611645
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    # 422, Sasang-ro, Sasang-gu
    City
    Busan
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K171297

    Owner / Operator

    Firm Name
    Biotem Co., Ltd.
    Operator Number
    10057313
    Address
    # 422, Sasang-ro, Sasang-gu
    City
    Busan
    State
    KR-26
    Postal Code
    46925
    Country
    KR

    US Agent

    Business Name
    BIOTEM USA
    Contact Name
    Eunjin Yuwm
    Address
    1218 W Commonwealth Ave
    City
    Fullerton
    State
    CA
    ZIP
    92833
    Country
    US
    Email
    [email protected]
    Phone
    310 4087630

    Products

    Device Name Product Code
    Implant, Endosseous, Root-Form DZE
    Abutment, Implant, Dental, Endosseous NHA
    Accessories, Implant, Dental, Endosseous NDP
    Drill, Dental, Intraoral DZA
    Gauge, Depth, Instrument, Dental EIL
    Pin, Retentive And Splinting, And Accessory Instruments EBL

    Proprietary Names

    AR_N Type Implant System Primus Implant System AR_N Hand Driver Hand Driver IR Pick-Up Impression Coping BR Hand Driver Torque Wrench BR Pick-Up Impression Coping BR Transfer Impression Coping Transfer Impression Coping AR_N Fixture Lab Analog AR_N Transfer Impression Coping IR Fixture Lab Analog AR_N Solid Lab Analog Fixture Lab Analog Solid Lab Analog Pick-Up Impression Coping AR_N Pick-Up Impression Coping IR Solid Lab Analog BR Lab Analog BR Type Implant System Marking Drill Tapered Drill Point Drill Straight Drill Cortical Drill Drill Extension BR SLA Type Implant System IR Type Implant System IR Fixture Driver for Wrench IR Fixture Driver for Machine AR_N Fixture Driver for Machine Fixture Driver for Machine BR Fixture Driver for Machine AR_N Fixture Driver for Wrench BR Fixture Driver for Wrench Fixture Driver for Wrench Bone Level Fixture AR_N SLA Type Implant System Parallel Pin Fixture Pin IR SLA Type Implant System

    Establishment Types

    Manufacture Medical Device