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
- [email protected]
- Phone
- 714 8804141
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Controller, Foot, Handpiece And Cord | EBW | Class 1 | Dental | No | 2022-02-14 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2019-10-04 |
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2013-05-28 |
| Drill, Dental, Intraoral | DZA | Class 1 | Dental | No | 2013-07-02 |
| Additively Manufactured, Preformed, Resin Denture Tooth | PZY | Class 2 | Dental | No | 2020-08-30 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2018-07-24 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2022-11-17 |
| Handpiece, Direct Drive, Ac-Powered | EKX | Class 1 | Dental | No | 2018-09-03 |
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | NOF | Class 2 | Dental | No | 2021-07-28 |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | Class 2 | Dental | No | 2021-03-31 |
| Chisel, Osteotome, Surgical | EMM | Class 1 | Dental | No | 2008-02-22 |
| Wax, Dental, Intraoral | EGD | Class 1 | Dental | No | 2018-06-28 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2013-01-09 |
| Handpiece, Water-Powered | EKY | Class 1 | Dental | No | 2021-11-08 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2019-07-23 |
| Teeth, Artificial, Posterior With Metal Insert | ELJ | Class 1 | Dental | No | 2018-02-04 |
| Accessories, Retractor, Dental | EIF | Class 1 | Dental | No | 2017-02-03 |
| Attachment, Precision, All | EGG | Class 1 | Dental | No | 2013-11-20 |
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