Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007126709

FEI Number

3007126709

Entity Name

DIO Corporation

City/State/Country

Haeundae-gu Busan, KR

Establishment Address

66, Centumseo-ro, Haeundae-gu Busan 48058, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

DIO Corporation (Owner Number: 9089142)

Owner / Operator Contact Address

66, Centumseo-ro, --, Haeundae-gu, KR-26 48058, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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 SM Cemented Abutment SM Fixture FTN Conical Plastic Abutment FTN Cylinder Screw SM Solid Mill Abutment IFI Angled Abutment FTN Abutment Screw SM Angled Abutment 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 SM Mill Abutment UF(II) Abutment Screw 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 SM Healing Abutment FTN UCLA Plastic Abutment SM Abutment Screw SM Ball Abutment FTN Straight Fixture FTN Gold Cylinder for Conical Abutment SM Solid Abutment SM Solid Impression Cap SM Protect 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 UF(II) 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 UF(II) Anatomic abutment UF(II) Narrow Angled Abutment UF(II) Angled 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 UF(II) Internal Cemented Abutment 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 Fixture SM Dental Implant System UF(II) Internal Cover Screw DIO Ball Cap SM External Fixture UF(II) Internal Protect Cap UF(II) Internal Healing Cap IFI Angled Abutment UF(II) Internal Gold Cylinder UF(II) Internal Closing Screw UF(II) Internal Ball Abutment IFI Extension Cemented Abutment DIO IDx MEDIT-i900 MEDIT-i700 MEDIT-i500 MEDIT-i700 wireless DIOnavi-Denture02 DIO Osteotome DIO Osteotome Kit DIO Sinus Lift Kit Wave ST Osteotome

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EBW	Controller, Foot, Handpiece And Cord	Dental	Class 1	872.4200	2022-02-14
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2019-10-04
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2013-05-28
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2013-05-28
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2008-12-29
DZA	Drill, Dental, Intraoral	Dental	Class 1	872.4130	2013-07-02
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2008-12-29
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2008-12-29
PZY	Additively Manufactured, Preformed, Resin Denture Tooth	Dental	Class 2	872.3590	2020-08-30
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2018-07-24
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2008-12-29
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2008-12-29
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2008-12-29
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2018-06-03
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2022-11-17
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2017-03-15
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2017-03-15
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2020-02-24
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2019-10-01
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2008-02-18
EKX	Handpiece, Direct Drive, Ac-Powered	Dental	Class 1	872.4200	2018-09-03
NOF	System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	Dental	Class 2	872.3661	2021-07-28
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2021-03-31
EMM	Chisel, Osteotome, Surgical	Dental	Class 1	872.4565	2008-02-22

Official Correspondent

No official correspondent registered.

US Agent Details

Peter Kang Business: DIO USA CORPORATION Email: peter@dioimplantusa.com Phone: (714) 8804141

Related Public Records

Same Entity

DIO Corporation

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K040153	Indigenous Peoples Technology and Education Center	I-TEC PORTABLE DENTAL OPERATORY	2004-05-21
K211871	Faico Medical, LLC	FAICO Dental Implant System and CAD/CAM Abutments	2021-11-18
K081806	Idi Biomedical, LLC	IDI IMPLANT SYSTEM	2008-11-07
K120793	Z-Systems AG	Z-LOOK3 EVO SLM	2012-12-21
K130140	Intra-Lock International	INTRA-LOCK OP DENTAL IMPLANT	2013-08-01

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2018	Implant Direct Sybron Manufacturing, LLC	2	Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
Z-0010-2020	Implant Direct Sybron Manufacturing, LLC	2	ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
Z-0017-2026	S.I.N. Implant System Ltda Rua Soldador Ocimar Guimaraes da Silva 421 Jardim Analia Franco Sao Paulo Brazil	2	IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N; IMPLANT EPIKUT PLUS MT16 3,5X13,0MM, REF: ILM 3513N; IMPLANT EPIKUT PLUS MT16 3,5X15,0MM, REF: ILM 3515N; IMPLANT EPIKUT PLUS MT16 3,8X10,0MM, REF: ILM 3810N; IMPLANT CM16 3,8 X 11MM, REF: ILM 3811N; IMPLANT EPIKUT PLUS MT16 3,8X15,0MM, REF: ILM 3815N; IMPLANT EPIKUT PLUS MT16 4,0X10,0MM, REF: ILM 4010N; IMPLANT EPIKUT PLUS MT16 4,0X11,5MM, REF: ILM 4011N; IMPLANT EPIKUT PLUS MT16 4,0X13,0MM, REF: ILM 4013N; IMP EPIKUT PLUS LONG MT16 4,0X20,0MM, RES: ILM 4020N; IMPLANT EPIKUT PLUS MT16 4,0X8,5MM, RES: ILM 4085N; IMPLANT EPIKUT PLUS MT16 4,5X13,0MM, REF: ILM 4513N; IMPLANT EPIKUT PLUS MT16 4,5X15,0MM, REF: ILM 4515N; IMPLANT EPIKUT PLUS MT16 4,5X8,5MM, REF: ILM 4585N; IMPLANT EPIKUT PLUS MT16 5,0X10,0MM, REF: ILM 5010N; IMPLANT EPIKUT PLUS MT16 5,0X11,5MM, REF: ILM 5011N; IMPLANT EPIKUT PLUS MT16 4,5X10,0MM, REF: ILM 4510N; IMPLANT EPIKUT PLUS MT16 5,0X13,0MM, RES: ILM 5013N; IMPLANT EPIKUT PLUS MT16 5,0X15,0MM, REF: ILM 5015N; IMPLANT EPIKUT PLUS MT16 5,0X8,5MM, REF: ILM 5085N; IMP EPIKUT PLUS LONG MT16 4,0X18,0MM, REF: ILM 4018N; IMP EPIKUT PLUS LONG MT16 3,8X18,0MM, REF: ILM 3818N; IMPLANT EPIKUT PLUS MT16 4,5X11,5MM, REF: ILM 4511N; IMPLANT EPIKUT MT16 4,5X15,0MM, REF: ILM 4515; IMPLANT EPIKUT MT16 4,5X8,5MM, REF: ILM 4585; IMPLANT EPIKUT MT16 3,8X13,0MM, REF: ILM 3813; IMPLANT EPIKUT MT16 3,8X15,0MM, REF: ILM 3815; IMPLANT EPIKUT MT16 5,0X8,5MM, REF: ILM 5085; IMPLANT EPIKUT MT16 3,8X11,5MM, REF: ILM 3811; IMPLANT EPIKUT PLUS MT16 3,8X20,0MM, REF: ILM 3820N; IMPLANT EPIKUT PLUS MT16 4,5X18,0MM, REF: ILM 4518N; IMPLANT UNITITE MORSE COMPACT 6.0X7MM, REF: UCMC 6007N
Z-0018-2020	Implant Direct Sybron Manufacturing, LLC	2	ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The responsible firm on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. - Product Usage:Implant Direct Sybron Manufacturing LLC s dental implant product line consists of one-piece and two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Z-0019-2020	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	2	Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007126709. Last updated year: 2026. Please use registration number 3007126709 when referencing this establishment in official correspondence.