BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    POINTIMPLANT Co., Ltd

    Reg #: 3011891801 · FEI: 3011891801 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    69
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    POINTIMPLANT Co., Ltd
    Registration Number
    3011891801
    FEI Number
    3011891801
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    B1 and 3F, 7, Hyoyeol-ro, Buk-gu
    City
    Busan
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K222738

    Owner / Operator

    Firm Name
    PointImplant Co Ltd
    Operator Number
    10083213
    Address
    B1 and 3F, 7, Hyoyeol-ro, Buk-gu
    City
    Busan
    State
    KR-26
    Postal Code
    46509
    Country
    KR
    Correspondent
    Joarak Chung

    US Agent

    Business Name
    Mtech Group LLC
    Contact Name
    Dave Kim
    Address
    7505 Fannin St Ste 610
    City
    Houston
    State
    TX
    ZIP
    77054
    Country
    US
    Email
    [email protected]
    Phone
    713 4672607

    Products

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

    Proprietary Names

    Abutment Screw Fixture Mount Healing Abutment Temporary Abutment SM II Fixture Solid Cap Solid Abutment Cemented Abutment Angled Abutment Fixture Mount Screw Cover Screw Bone Profile Drill Cortical Drill SideCut Drill Lance Drill Tissue Punch Drill Fixture Tap Drill Point Drill Final Drill Initial Drill Remove Driver Solid Driver Multi Guide Pin NAVI-KIT Ball Abutment Driver Guide pin Bite Impression Coping Cap Multi Abutment Carrier Torque Extension Abutment Removal Tip Transfer Impression coping Parallel Pin Fixture Driver Multi Abutment Driver Ratchet Wrench Digital Lab Analog Torque Wrench Fixture analog Scan Body Screw Mount Driver Pincette Slot Driver No-Mount Driver OTS-KIT OTA-KIT Mount Extension PRO-KIT Bite Scan Body BITE-KIT Hand Driver Scan Body Multi Impression Coping Machine Screw Driver Fixture pin Depth Gage Drill Extension Bite Impression Coping Lab analog Impression Coping Driver Excellent Solid Analog Pick-Up Impression Coping Stopper Drill Tube Ball Analog Plastic Sleeve Torque Driver OT-KIT Mount Open Wrench Vertical Anchor

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device