BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    Oneday Biotech Co., Ltd.

    Reg #: 3017548645 · FEI: 3017548645 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    37
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Oneday Biotech Co., Ltd.
    Registration Number
    3017548645
    FEI Number
    3017548645
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    135 C SEONGSEODONGRO DALSEOGU
    City
    DAEGU
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K222946

    Owner / Operator

    Firm Name
    Oneday Biotech Co., Ltd.
    Operator Number
    10078125
    Address
    135 C SEONGSEODONGRO DALSEOGU
    City
    DAEGU
    State
    KR-NOTA
    Postal Code
    42721
    Country
    KR
    Correspondent
    SONG JAE HYUN

    US Agent

    Business Name
    LK Consulting Group USA, Inc.
    Contact Name
    Priscilla Chung
    Address
    2552 Walnut Ave Ste 230
    City
    Tustin
    State
    CA
    ZIP
    92780
    Country
    US
    Email
    [email protected]
    Phone
    714 9225276

    Products

    Device Name Product Code
    Implant, Endosseous, Root-Form DZE
    Abutment, Implant, Dental, Endosseous NHA
    Accessories, Implant, Dental, Endosseous NDP

    Proprietary Names

    Oneday Mini Implant System Oneday Biotech Implant I DO IMPLAMT Taper Drill-1 Drill Stopper Unigrip Driver for Ratchet Mount Driver (Ratchet) Taper Drill-2 1.25 Hex Driver for Ratchet Oneday Guide KIT [OGK] Intraoral Scan Body Oneday Guide Sinus KIT [OGSK] Lab Analog Driver Connector Multi unit Lab analog Pararlle Pin One Drill Plus KIT [ODPK] SCS Driver for Ratchet Torque Wrench Mount Driver (Machine) Complete Kit (KIT001, KIT002) Depth Pin Drill Extension 1.2 Hex Driver for Ratchet Digital Lab Analog Universal Prosthetic Kit (IPDK) Bone Expander Screw Driver (Ratchet) Ti-Base Screw Driver (Machine) Digital Multi Unit Analog Profile Drill Lindemann Drill Twist Drill Scan Body One Drill KIT [ODK] Oneday Implant Abutment

    Establishment Types

    Manufacture Medical Device