FDA Registration Active 🇰🇷 South Korea

DIO Corporation

Reg #: 3007126709 · FEI: 3007126709 · Expires 2026
Products
18
Proprietary Names
511
Establishment Types
3
Classifications
18

Registration Details

Registration Name
DIO Corporation
Registration Number
3007126709
FEI Number
3007126709
Status
Active
Expiry Year
2026
Initial Importer
No
Address
66, Centumseo-ro
City
Haeundae-gu Busan
Country
KR

Regulatory Submissions

510(k) Number
K092758

Owner / Operator

Firm Name
DIO Corporation
Operator Number
9089142
Address
66, Centumseo-ro, --
City
Haeundae-gu
State
Busan
Postal Code
48058
Country
KR

US Agent

Business Name
DIO USA CORPORATION
Contact Name
Peter Kang
Address
1932 E Deere Ave Ste 100
City
Santa Ana
State
CA
ZIP
92705
Country
US
Phone
714 8804141

Products

Device Name Product Code
Controller, Foot, Handpiece And Cord EBW
Abutment, Implant, Dental, Endosseous NHA
Implant, Endosseous, Root-Form DZE
Drill, Dental, Intraoral DZA
Additively Manufactured, Preformed, Resin Denture Tooth PZY
System, Image Processing, Radiological LLZ
Instruments, Dental Hand DZN
Handpiece, Direct Drive, Ac-Powered EKX
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations NOF
Resin, Denture, Relining, Repairing, Rebasing EBI
Chisel, Osteotome, Surgical EMM
Wax, Dental, Intraoral EGD
Accessories, Implant, Dental, Endosseous NDP
Handpiece, Water-Powered EKY
Tray, Impression, Preformed EHY
Teeth, Artificial, Posterior With Metal Insert ELJ
Accessories, Retractor, Dental EIF
Attachment, Precision, All EGG

Proprietary Names

SURGICUBE UF(II) Anatomic abutment UF Implant System UF(II) Extra Wide Fixture UF(II) Fixture UF(II) Internal Temporary Cylinder UF(II) Angled Abutment UF(II) Mill Abutment UF(II) Temporary Abutment UF(II) Cover Screw UFIII Fixture DIO UF USA Internal Sub-Merged Implant System UF(II) Solid Abutment UF(II) Transfer Coping IFI Gold Cylinder UF(II) Ball Abutment UF(II) Internal Gold Cylinder UF(II) Internal Cemented Cylinder UF(II) Protect Cap UF(II) Cemented Abutment UF(II) UCLA Gold Abutment UF(II) Healing Abutment UF(II) Octa Abutment UF(II) Internal Healing Cap SM Extra Wide Implant System UF(II) Trephine Drill DIOnavi. Point Straight Drill UF(II) External Counter Sinker Sinus Lift ST Drill DIOnavi. Initial Drill DIO Starter Drill DIOnavi. Tissue Punch Sinus Expansion Drill DIO Round Drill DIOnavi. Connector Extension Sinus Lift Drill DIOnavi. Guide Drill DIO Osteotome Kit DIonavi. Abutment Profile Drill Sinus Osteotome KIT DIOnavi. Initial Positioning Drill UF(II) Bone Profile Drill DIO Flapless Crestal Sinus kit DIO Sinus Lift Kit DIO Sinus Master Kit UF(II) Narrow Surgical Kit Healing Contour DIO Initial Drill UF(II) Prosthetic Planning Kit DIO Bone Expander Kit UF(II) Internal Counter Sinker DIO Drill Extension Cover SET DIO Sinus Kit UF(II) Tap Drill DIOnavi. Profile Drill UF(II) Guide Side Cut Drill UF(II) Lindemann Drill DIO Dr.SOS+ Kit UF(II) Narrow Tap Drill DIO Dr.SOS plus Kit UF(II) Internal Tap Drill DIO Sinus Trephine Drill DIOnavi. Straight Drill DIO New Dr. SOS+ Kit Pre-bone Flattening Drill FTN Counter Sinker DIO Pilot Drill DIOnavi. Anchor Drill DIO Sinus Round Drill DIO Straight Drill DIOnavi. Trainer's Kit Multi Initial ST Drill DIO Drill Extension Cover DIO Sinus Approach Round Drill UF(II) Starter Kit Deep Bone Flattening Drill UF(II) Internal Count Sinker Tissue Punch DIO Master Kit Straight Drill FTN Surgical Kit Drill Extension Cover Set DIO Master S Kit Taper Drill FTN Tapered Drill DIO MIT KIT Position Drill Protem Straight Drill UniCon KIT Sinus Drill KIT DIO Drill Extension DIO Sinus Approach Lateral Round Drill UF(II) Profile Drill DIO Dr. SOS+ Kit UF(II) Internal Master Kit DIO Reverse Cutting Drill DIOnavi. Bone Flattening Drill UF(II) Straight Drill Connector Extension DIOnavi. Special Kit UF(II) Initial Drill UF(II) Wide Surgical Kit Modify Bur DIO Guide Drill Protem Tissue Punch Cortical Drill Protem Surgical Kit Multi Initial Drill DIO Surgical Kit FSN Straight Drill DIO SM Implant System UF(II) Abutment Screw SM Fixture SM Abutment Screw SM Cemented Abutment SM Angled Abutment SM Cover Screw SM Mill Abutment SM Solid Abutment (II) SM Ball Abutment SM Cemented Abutment (II) SM Healing Abutment SM Octa Abutment SM Protect Cap DIOnavi. C&B DIOnavi-P. MAX DIOnavi. C&B Z Implant Studio™ DIO Dental Implant System FTN Plastic Cylinder for Conical Abutment FTN Ball Abutment FTN Temporary Cylinder FTN Cemented Abutment FTN Conical Abutment FTN Conical Plastic Abutment FTN Cylinder Screw SM Solid Mill Abutment IFI Angled Abutment FTN Abutment Screw FTN Healing Cap SM Transfer Impression Coping SM Impression Cap FTN External Fixture UF(II) Internal Cemented Abutment FTN Fixture FTN Conical Abutment Screw PSI Fixture FTN Cover Screw SM Temporary Abutment FTN Headless Screw IFI Fixture FTN Healing Abutment IFI Extension Cemented Abutment FTN Temporary Abutment FTN UCLA Gold Abutment Healing Abutment FTN UCLA Plastic Abutment FTN Straight Fixture FTN Gold Cylinder for Conical Abutment SM Solid Abutment SM Solid Impression Cap UF(II) Transfer Impression Coping FSN Fixture FTN Angled Abutment SM UCLA Gold Abutment Dio Protem Implant System Protem Ball Fixture Protem Post Fixture Protem Ball Cap UF(II) Wide Fixture Protem Stopper Holder(4mm) UF(II) narrow Jig Cylinder DIO ORTHO 3430 TOOL Protem Fixture Driver Assy FTN Fixture Driver DIO Solid Abutment Driver DIOnavi. Stopper UF(II) Internal Fixture Driver DIO Screw Driver Ratchet Wrench (Nobel) DIO Octa Abutment Holder UF(II) Ratchet Screw Driver DIO Conical Abutment Driver DIO Tap Adapter DIO Remove Bar Crestal Elevator DIO Multi Screw Driver DIO Membrane Lifter Tube DIO Screw Driver DIO ORTHO 4238 TOOL DIO Anchor Screw Driver DIo Slot Driver Bone File Protem Fixture Driver UF(II) Multiunit Angled Abutmeng Jig UF(II) Narrow Solid Abutment Driver DIO Sinus Approach Bone Condenser DIO Square Wrench DIO Remove Bar Handel DIO Abutment Removing Driver Reverse Tweezer DIonavi. Metal Needle Tip Short DIO Water Membrane Lifter DIO Fixture Driver assy (Machine) DIO Ball Abutment Holder DIO Ratchet Adapter DIO Multi Straight Abutment Holder DIO Drill Stopper DIO Internal Fixture Removing Driver DIOnavi. Metal Needle Tip Extra Long UF(II) Abutment Carrier DIO Sinus Approach Stopper Protem Fixtrure Driver(Ratchet) DIO Ball Abutment Driver DIo Reamer Set DIO Octa Abutment Driver DIO Fixture Driver(Machine) DIO Screw Guide Tap DIO Screw Remove DIO Square Hex Screw Driver DIOnavi. Drill Tube DIO Fixture Driver(Ratchet) UF(II) Narrow Fixture Driver Contra Angle DIO Fixture Removing Driver DIo Torque Wrench DIO MALLET DIO Sinus Elavator DIO Square Handle DIO Mount Driver UF(II) H-Scan Body Jig DIO Machine Screw Driver Beak Action Chisel DIO Fixture Driver UF(II) Narrow Fixture Driver Ratchet Wrench DIO Guide Sinus Approach Depth Gauge Protem Stopper FTN Fixture Mount Driver DIo Ratchet Wrench DIO Sinus Approach Depth Gauge Sinus Membrane Detach tool DIo Depth Gauge UF(II) Internal Fixture Mount Driver DIonavi. Metal Needle Tip Long DIO Removing Driver UF(II) Internal Depth Gauge Periosteal Elevator Protem Stopper Holder(2mm) FTN Depth Gauge DIO Guide Sinus Approach Stopper DIO Open Wrench DIO 0.8 Slot Driver Bone Condenser Protem Fixture Driver(Machine) DIO Multi Unit Abutment Holder DIO Fixture Driver assy (Ratchet) DIO Multi Angled Abutment Holder Double Depth Gauge 1.2 Hex Driver Stopper(Sinus Approach) UF(II) Narrow Implant System UF(II) Narrow Cover Screw UF(II) Narrow Ball Abutment UF(II) Narrow Angled Abutment UF(II) Narrow Temporary Abutment UF(II) Narrow Healing Abutment UF(II) Narrow Solid Abutment UF(II) Narrow Fixture UF(II) Narrow Multi Unit Abutment UF(II) Narrow Cemented Abutment UF(II) Narrow Abutment Screw UF(II) Narrow UCLA CCM Abutment UCLA CCM Abutment UF(II) UCLA CCM Abutment SM Internal/External Implant System IFI Cover Screw UF(II) Internal Fixture FSN UCLA Plastic Abutment UF(II) Internal Octa Abutment SM Internal Fixture UF(II) Internal Healing Abutment UF(II) Internal Solid Abutment IFI Healing Cap DIO Retainer UF(II) Internal Excellent Solid Abutment UF(II) Internal Plastic Cylinder UF(II) Internal Extension Cemented Abutment UF(II) Internal Angled Abutment IFI Healing Abutment SM Dental Implant System UF(II) Internal Cover Screw DIO Ball Cap SM External Fixture UF(II) Internal Protect Cap UF(II) Internal Closing Screw UF(II) Internal Ball Abutment DIO IDx MEDIT-i900 MEDIT-i700 MEDIT-i500 MEDIT-i700 wireless DIOnavi-Denture02 DIO Osteotome Wave ST Osteotome Wax Denture UF(II) Multi Low Post Scan Adapter UF(II) Scan Adapter UF H-Scan Body Screw UF(II) Abutment Analog UF(II) Healing Cap Screw UF(II) Narrow Scan Adapter UF(II) Narrow H-Scan Body UF(II) Parallel Pin UF(II) Internal Pick-up Impression Coping Screw UF(II) Narrow DA Protect Cap FSN Fixture Mount UF(II) Healing Cap UF(II) Bar Holder Abutment Clip Carrier UF(II) Digital Lab Analog Jig UF(II) Bar Holder Abutment Clip UF(II) Internal Pre-Milled Bar DIO Water Membrane Lifter Body Veltz-SG UF(II) UCLA Plastic Abutment UF(II) Internal Excellent Plastic Coping UF(II) Plastic Coping UF Fixture Mount UF(II) Internal Pick-up Impression Coping DIO Fixture Analog DIOnavi. Anchor Screw UF(II) Internal Positioning Cylinder Protem Fixture Analog DIO Water Membrane Lifter Tube UF(II) Cylinder Scanbody UF(II) Internal Solid Abutment Analog UF(II) Eco Pickup Impression Coping DIO Scan Adapter UF(II) Guide Pin UF(II) Internal Exellent Impression Cap DIOnavi. Abutment Jig FTN Pre-milled Bar DIOnavi-C&B UF(II) Narrow Transfer Impression Coping Screw FTN Ball Abutment Analog DIOnavi. Surgical Guide Fix Pin UF(II) Narrow Solid Abutment Analog DIOnavi-C&B Z FTN Fixture Analog DIO Parallel Pin DIOnavi. Surgical Guide UF(II) Ball Abutment Analog UF(II) Narrow Transfer Impression Coping UF(II) Pre-Milled Bar UF(II) Solid Abutment Analog UF(II) DA Protect Cap UF(II) Internal Fixture Analog DIO External Guide SM Pick-up Impression Coping UF(II) Coping Screw Screw Holder UF(II) Internal Plastic Coping UF(II) Narrow Digital Lab Analog UF(II) Bar Holder Abutment Bar UF(II) Multi Cylinder Protector FTN Scan Adapter Screw UF(II) Narrow Trasfer Impression Coping DIOnavi. Surgical Guide Fix UF(II) H-Scan Body UF(II) Internal Transfer Impression Coping UF(II) Impression Cap FTN Scan Adapter UF(II) Fixture Analog UF(II) Internal H-Scan Body DIO Reamer Pin DIO LOCA H-Scan Body UF(II) Narrow Protect Cap UF(II) Pick-up Impression Coping UF(II) Internal Shoulder Analog UF(II) Eco Guide Pin UF(II) Narrow Guide pin UF(II) Eco Digital Coping Screw Screw Remove Tip UF(II) Eco Bite Impression Coping DIOnavi. Guide (Anchor system) DIOnavi. Implant Connector UF(II) Internal Guide Pin Veltz-C&B UF(II) Eco H-Scan Body UF(II) Bar HOlder Abutment Analog UF(II) Internal Cast Abutment UF(II) Narrow Fixture Analog DIOnavi. Guide sleeve UF(II) Narrow Pick-up Impression Coping SM Guide Pin DIOnavi-SG UF(II) Angled Parallel Pin FTN Transfer Impression Coping Screw SM Positioning Guide UF(II) Narrow Scan Adapter Screw ITI Scan Adapter FTN Conical Abutment Analog UF(II) Internal Fixture Mount FTN Fixture Mount Screw UF(II) Path Pin UF(II) Internal Octa Abutment Analog Universal Fixture Removing Driver Initial Check Pin DIO H-Scan Body FTN Transfer Impression Coping UF(II) Internal Impression Cap UF(II) Angled Path Pin UF(II) Scan Adapter Screw FTN Fixture Mount UF(II) Eco Coping Screw FTN Guide Pin UF(II) Transfer Impression Coping Screw UF Plastic Cylinder DIonavi. Marker UF(II) Digital Lab Analog UF(II) Internal Guide DIonavi. Anchor sleeve Protem Impression Coping DIOnavi. Guide UF(II) Narrow Internal Guide UF(II) Internal Impression Coping Screw DIO Scan Adapter Screw UF(II) Multi Low Post Pick-up Impression Coping UF(II) Bar Holder Clip FTN Impression Coping Screw DIO O-Ring UF(II) Multi Low Post Digital Lap Analog FSN Straight Drill Stopper Holder FTN H-Scan Body UF(II) Narrow Guide Pin DIO Pick-up Impression Coping FTN Conical Plastic Cylinder Multi Guider UF(II) Multi Low Post Abutment Analog Multi-unit Selector Straight Drill Stopper UF(II) Multi Low Post Abutment Holder UniCon KIT 5 Surgical Guide SICON Surgical KIT UF(II) Multi Low Post H-ScanBody Final Check Pin UF(II) Multi Low Post Plastic Cylinder Fixture Driver(Engine) Multi-unit Selector KIT UF(II) Multi Low Post Transfer Impression Coping UF(II) Multi Low Post Cylinder Protector UniCon KIT 3 UF(II) Multi Low Post Abutment Coping UF(II) Multi Low Post EaStab Cylinder Semi Final UF(II) Multi Low Post Cylinder ScanBody TRAUS SM(R) IMPLANT SYSTEM SM-Extra Wide(RBM) Implant System SM Extra Wide Fixture UF(II) Customized Abutment UF(II) Hybrid Link UF(II) Narrow Customized Abutment UF Customized Abutment DIO CAD/CAM Abutment UF(II) Narrow Hybrid Link DIO Customized Abutment UF(II) Implant System UF(II) Angled Abutment Screw UF(II) Internal Cylinder Screw UF(II) Solid Abutment (II) UF(II) Digital Abutment Screw UF(II) Narrow Conical Abutment UF(II) Cemented Abutment (II) UF(II) Conical Abutment DIOnavi-High C&B DIOnavi-C&B F DIOnavi-Denture UF(II) Eco Healing Cap UF(II) Eco Angled Post UF(II) Eco Post Screw UF(II) Eco Cemented Post UF(II) Multi Straight Abutment UF(II) Eastab Cylinder Semi Final UF(II) Multi Angled Abutment UF(II) Eco Base Abutment UF(II) Temporary Cylinder Semi Final UF(II) Eastab Cylinder UF(II) Eco Base Screw UF(II) Eco Temporary Post UF(II) Temporary Cylinder UF(II) Cylinder Screw UF(II) Bar Holder Abutment Bar holder Abutment Bar holder Cap Abutment UF(II) Bar holder Cap Abutment UF(II) Bar holder Abutment Set Screw UF(II) Narrow Bar holder Cap Abutment DIO STEADY External Implant System FTN Tapered Fixture UF(II) External Straight Fixture Secure Implant System(2.5/3mm) Protem Healing Cap Protem Cemented Abutment DIOnavi. Scan Retractor Lower jaw Set DIOnavi. Scan Retractor Upper jaw DIOnavi. Scan Retractor Upper jaw Set DIOnavi. Scan Retractor Lower jaw UV Active Implant System UF(II) Narrow Mill Abutment UF(II) Narrow CCM Cylinder UF(II) Cemented Cylinder UF(II) Multi Angled Abutment Screw OT CAP

Establishment Types

Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device Repack or Relabel Medical Device