BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    DIMPLO Ltd.

    Reg #: 3042971970 · FEI: 3042971970 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    73
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    DIMPLO Ltd.
    Registration Number
    3042971970
    FEI Number
    3042971970
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2F, 16, Hwangsaeal-ro
    City
    Yeonje-gu Busan
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K251605

    Owner / Operator

    Firm Name
    DIMPLO Ltd.
    Operator Number
    10094913
    Address
    2F, 16, Hwangsaeal-ro
    City
    Yeonje-gu
    State
    Busan
    Postal Code
    47507
    Country
    KR
    Correspondent
    Jiyeon Sung

    US Agent

    Business Name
    Inpixel Store LLC
    Contact Name
    Sukjoon Chung
    Address
    15707 Rockfield Blvd Ste 110
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US
    Email
    [email protected]
    Phone
    213 7000812

    Products

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

    Proprietary Names

    DIMPLO Implant System Taper Drill Cortical Drill Guide Final Drill Guide Socket Drill Sidecut Drill Guide Sinus Round Drill Guide Step Drill Round Drill Final Drill Guide Path Drill Lance Drill Core Drill Guide Initial Drill Initial Drill Guide Sinus Final Drill Anchor Drill Twist Drill Bone Flat Drill C Stopper 12mm L Stopper 2.5mm C Stopper 11mm Handle Surgical Taper Kit Sinus Master Kit C Stopper Holder L Stopper 1.5mm C Stopper 5mm Prosthetic Kit Sinus Curette (Medium) Carrier Bone Profiler Sinus Curette (Small) Mushroom Sinus Elevator C Stopper 2mm Depth Gauge Wide Sinus Elevator Surgical Wide Kit C Stopper 6mm Anchor Driver C Stopper 3mm ASC Driver Anchor Screw Adapter Extension Membrane Lifter C Stopper 1mm Parallel Pin Guidaz Kit Angled Sinus Elevator L Stopper 3mm L Stopper Holder Sinus Guidaz Kit C Stopper 8mm Torque Wrench C Stopper 9mm Multi Abut Driver Depth Gauge - Sinus Bone Condenser - Sinus Fixture Driver C Stopper 7mm Tissue Punch C Stopper 10mm Membrane Lifter Syringe Square Wrench Sinus Lift Kit Bone Condenser Hex Driver Membrane Lifter Tube L Stopper 1mm Drill Extension C Stopper 4mm L Stopper 2mm L Stopper 0.5mm

    Establishment Types

    Manufacture Medical Device