Manufacturer registered with FDA
DIO Corporation
Haeundae-gu, South Korea. Lists 17 dental device types with FDA across 1 registered establishment, and holds 14 510(k) clearances as applicant.
- Device types listed
- 17
- Brands and models
- 630
- 510(k) clearances
- 142010–2023
- Markets registered in
- 435 registrations outside the US
- Establishments
- 1South Korea
510(k) clearances per year, 2007–2026
Registered in 4 markets
Where regulators' registries name DIO Corporation as the manufacturer or the registration holder of a device.
RegisteredHome: South KoreaOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | DIO Corporation | 14 clearances | 2010–2023 | Below |
| Taiwan | TFDA | Manufacturer | DIO CORPORATIONDIO Corporation | 28 | 2008–2026 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | DIO CORPORATION | 4 | 2017–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | DIO CORPORATION | 3 | 2009–2009 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What DIO Corporation currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | DIO Ball CapDIO Dental Implant SystemDio Protem Implant SystemDIO RetainerDIO SM Implant SystemDIO STEADY External Implant SystemDIO UF USA Internal Sub-Merged Implant SystemFSN FixtureFSN UCLA Plastic AbutmentFTN Abutment Screw 128 moreFTN Angled AbutmentFTN Ball AbutmentFTN Cemented AbutmentFTN Conical AbutmentFTN Conical Abutment ScrewFTN Conical Plastic AbutmentFTN Cover ScrewFTN Cylinder ScrewFTN External FixtureFTN FixtureFTN Gold Cylinder for Conical AbutmentFTN Headless ScrewFTN Healing AbutmentFTN Healing CapFTN Plastic Cylinder for Conical AbutmentFTN Straight FixtureFTN Tapered FixtureFTN Temporary AbutmentFTN Temporary CylinderFTN UCLA Gold AbutmentFTN UCLA Plastic AbutmentHealing AbutmentIFI Angled AbutmentIFI Cover ScrewIFI Extension Cemented AbutmentIFI FixtureIFI Gold CylinderIFI Healing AbutmentIFI Healing CapProtem Ball CapProtem Ball FixtureProtem Cemented AbutmentProtem Healing CapProtem Post FixturePSI FixtureSecure Implant System(2.5/3mm)SM Abutment ScrewSM Angled AbutmentSM Ball AbutmentSM Cemented AbutmentSM Cemented Abutment (II)SM Cover ScrewSM Dental Implant SystemSM External FixtureSM Extra Wide FixtureSM Extra Wide Implant SystemSM FixtureSM Healing AbutmentSM Impression CapSM Internal FixtureSM Internal/External Implant SystemSM Mill AbutmentSM Octa AbutmentSM Protect CapSM Solid AbutmentSM Solid Abutment (II)SM Solid Impression CapSM Solid Mill AbutmentSM Temporary AbutmentSM Transfer Impression CopingSM UCLA Gold AbutmentSM-Extra Wide(RBM) Implant SystemSM(R) IMPLANT SYSTEMUF Implant SystemUF(II) Abutment ScrewUF(II) Angled AbutmentUF(II) Angled Abutment ScrewUF(II) Ball AbutmentUF(II) Cemented AbutmentUF(II) Cemented Abutment (II)UF(II) Cemented CylinderUF(II) Conical AbutmentUF(II) Cover ScrewUF(II) Cylinder ScrewUF(II) Digital Abutment ScrewUF(II) External Straight FixtureUF(II) Extra Wide FixtureUF(II) FixtureUF(II) Healing AbutmentUF(II) Implant SystemUF(II) Internal Angled AbutmentUF(II) Internal Ball AbutmentUF(II) Internal Cemented AbutmentUF(II) Internal Cemented CylinderUF(II) Internal Closing ScrewUF(II) Internal Cover ScrewUF(II) Internal Cylinder ScrewUF(II) Internal Excellent Solid AbutmentUF(II) Internal Extension Cemented AbutmentUF(II) Internal FixtureUF(II) Internal Gold CylinderUF(II) Internal Healing AbutmentUF(II) Internal Healing CapUF(II) Internal Octa AbutmentUF(II) Internal Plastic CylinderUF(II) Internal Protect CapUF(II) Internal Solid AbutmentUF(II) Internal Temporary CylinderUF(II) Mill AbutmentUF(II) Multi Angled AbutmentUF(II) Multi Angled Abutment ScrewUF(II) Multi Straight AbutmentUF(II) Narrow Abutment ScrewUF(II) Narrow Angled AbutmentUF(II) Narrow Ball AbutmentUF(II) Narrow CCM CylinderUF(II) Narrow Cemented AbutmentUF(II) Narrow Conical AbutmentUF(II) Narrow Cover ScrewUF(II) Narrow FixtureUF(II) Narrow Healing AbutmentUF(II) Narrow Implant SystemUF(II) Narrow Mill AbutmentUF(II) Narrow Multi Unit AbutmentUF(II) Narrow Solid AbutmentUF(II) Narrow Temporary AbutmentUF(II) Octa AbutmentUF(II) Protect CapUF(II) Solid AbutmentUF(II) Solid Abutment (II)UF(II) Temporary AbutmentUF(II) Temporary CylinderUF(II) Transfer CopingUF(II) Transfer Impression CopingUF(II) UCLA Gold AbutmentUF(II) Wide FixtureUFIII FixtureUV Active Implant System | 2006 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | Bar holder AbutmentBar holder Cap AbutmentDIO CAD/CAM AbutmentDIO Customized AbutmentDIO Dental Implant SystemDIO SM Implant SystemDIO UF USA Internal Sub-Merged Implant SystemFSN FixtureFTN Abutment ScrewFTN Angled Abutment 121 moreFTN Ball AbutmentFTN Cemented AbutmentFTN Conical AbutmentFTN Conical Abutment ScrewFTN Conical Plastic AbutmentFTN Cover ScrewFTN Cylinder ScrewFTN External FixtureFTN FixtureFTN Gold Cylinder for Conical AbutmentFTN Headless ScrewFTN Healing AbutmentFTN Healing CapFTN Plastic Cylinder for Conical AbutmentFTN Straight FixtureFTN Temporary AbutmentFTN Temporary CylinderFTN UCLA Gold AbutmentFTN UCLA Plastic AbutmentHealing AbutmentIFI Angled AbutmentIFI Extension Cemented AbutmentIFI FixtureIFI Gold CylinderPSI FixtureSM Abutment ScrewSM Angled AbutmentSM Ball AbutmentSM Cemented AbutmentSM Cemented Abutment (II)SM Cover ScrewSM Extra Wide FixtureSM FixtureSM Healing AbutmentSM Impression CapSM Mill AbutmentSM Octa AbutmentSM Protect CapSM Solid AbutmentSM Solid Abutment (II)SM Solid Impression CapSM Solid Mill AbutmentSM Temporary AbutmentSM Transfer Impression CopingSM UCLA Gold AbutmentSM-Extra Wide(RBM) Implant SystemUCLA CCM AbutmentUF Customized AbutmentUF Implant SystemUF(II) Abutment ScrewUF(II) Anatomic abutmentUF(II) Angled AbutmentUF(II) Angled Abutment ScrewUF(II) Ball AbutmentUF(II) Bar Holder AbutmentUF(II) Bar holder Abutment Set ScrewUF(II) Bar holder Cap AbutmentUF(II) Cemented AbutmentUF(II) Cemented Abutment (II)UF(II) Cemented CylinderUF(II) Conical AbutmentUF(II) Cover ScrewUF(II) Customized AbutmentUF(II) Cylinder ScrewUF(II) Digital Abutment ScrewUF(II) Eastab CylinderUF(II) Eastab Cylinder Semi FinalUF(II) Eco Angled PostUF(II) Eco Base AbutmentUF(II) Eco Base ScrewUF(II) Eco Cemented PostUF(II) Eco Healing CapUF(II) Eco Post ScrewUF(II) Eco Temporary PostUF(II) Extra Wide FixtureUF(II) FixtureUF(II) Healing AbutmentUF(II) Healing CapUF(II) Hybrid LinkUF(II) Implant SystemUF(II) Internal Cemented AbutmentUF(II) Internal Cemented CylinderUF(II) Internal Cylinder ScrewUF(II) Internal Gold CylinderUF(II) Internal Healing CapUF(II) Internal Temporary CylinderUF(II) Mill AbutmentUF(II) Multi Angled AbutmentUF(II) Multi Angled Abutment ScrewUF(II) Multi Straight AbutmentUF(II) Narrow Abutment ScrewUF(II) Narrow Angled AbutmentUF(II) Narrow Ball AbutmentUF(II) Narrow Bar holder Cap AbutmentUF(II) Narrow CCM CylinderUF(II) Narrow Cemented AbutmentUF(II) Narrow Conical AbutmentUF(II) Narrow Cover ScrewUF(II) Narrow Customized AbutmentUF(II) Narrow FixtureUF(II) Narrow Healing AbutmentUF(II) Narrow Hybrid LinkUF(II) Narrow Implant SystemUF(II) Narrow Mill AbutmentUF(II) Narrow Multi Unit AbutmentUF(II) Narrow Solid AbutmentUF(II) Narrow Temporary AbutmentUF(II) Narrow UCLA CCM AbutmentUF(II) Octa AbutmentUF(II) Protect CapUF(II) Solid AbutmentUF(II) Solid Abutment (II)UF(II) Temporary AbutmentUF(II) Temporary CylinderUF(II) Temporary Cylinder Semi FinalUF(II) Transfer CopingUF(II) Transfer Impression CopingUF(II) UCLA CCM AbutmentUF(II) UCLA Gold AbutmentUFIII FixtureUV Active Implant System | 2008 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | DIOnavi-DentureDIOnavi-Denture02 | 2020 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | Connector ExtensionCortical DrillDeep Bone Flattening DrillDIO Bone Expander KitDIO Dr. SOS+ KitDIO Dr.SOS plus KitDIO Dr.SOS+ KitDIO Drill ExtensionDIO Drill Extension CoverDIO Drill Extension Cover SET 77 moreDIO Flapless Crestal Sinus kitDIO Guide DrillDIO Initial DrillDIO Master KitDIO Master S KitDIO MIT KITDIO New Dr. SOS+ KitDIO Osteotome KitDIO Pilot DrillDIO Reverse Cutting DrillDIO Round DrillDIO Sinus Approach Lateral Round DrillDIO Sinus Approach Round DrillDIO Sinus KitDIO Sinus Lift KitDIO Sinus Master KitDIO Sinus Round DrillDIO Sinus Trephine DrillDIO Starter DrillDIO Straight DrillDIO Surgical KitDIonavi. Abutment Profile DrillDIOnavi. Anchor DrillDIOnavi. Bone Flattening DrillDIOnavi. Connector ExtensionDIOnavi. Guide DrillDIOnavi. Initial DrillDIOnavi. Initial Positioning DrillDIOnavi. Point Straight DrillDIOnavi. Profile DrillDIOnavi. Special KitDIOnavi. Straight DrillDIOnavi. Tissue PunchDIOnavi. Trainer's KitDrill Extension Cover SetFSN Straight DrillFTN Counter SinkerFTN Surgical KitFTN Tapered DrillHealing ContourModify BurMulti Initial DrillMulti Initial ST DrillN Implant KITPosition DrillPre-bone Flattening DrillProtem Straight DrillProtem Surgical KitProtem Tissue PunchSinus Drill KITSinus Expansion DrillSinus Lift DrillSinus Lift ST DrillSinus Osteotome KITStraight DrillTaper DrillTissue PunchUF(II) Bone Profile DrillUF(II) External Counter SinkerUF(II) Guide Side Cut DrillUF(II) Initial DrillUF(II) Internal Count SinkerUF(II) Internal Counter SinkerUF(II) Internal Master KitUF(II) Internal Tap DrillUF(II) Lindemann DrillUF(II) Narrow Surgical KitUF(II) Narrow Tap DrillUF(II) Profile DrillUF(II) Prosthetic Planning KitUF(II) Starter KitUF(II) Straight DrillUF(II) Tap DrillUF(II) Trephine DrillUF(II) Wide Surgical KitUniCon KITUNICON Navi KIT | 2013 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | Beak Action ChiselBone CondenserBone FileCrestal ElevatorDIO 0.8 Slot DriverDIO Abutment Removing DriverDIO Anchor Screw DriverDIO Ball Abutment DriverDIO Ball Abutment HolderDIO Conical Abutment Driver 78 moreDIo Depth GaugeDIO Drill StopperDIO Fixture DriverDIO Fixture Driver assy (Machine)DIO Fixture Driver assy (Ratchet)DIO Fixture Driver(Machine)DIO Fixture Driver(Ratchet)DIO Fixture Removing DriverDIO Guide Sinus Approach Depth GaugeDIO Guide Sinus Approach StopperDIO Internal Fixture Removing DriverDIO Machine Screw DriverDIO MALLETDIO Membrane Lifter TubeDIO Mount DriverDIO Multi Angled Abutment HolderDIO Multi Screw DriverDIO Multi Straight Abutment HolderDIO Multi Unit Abutment HolderDIO Octa Abutment DriverDIO Octa Abutment HolderDIO Open WrenchDIO ORTHO 3430 TOOLDIO ORTHO 4238 TOOLDIO Ratchet AdapterDIo Ratchet WrenchDIo Reamer SetDIO Remove BarDIO Remove Bar HandelDIO Removing DriverDIO Screw DriverDIO Screw Driver Ratchet Wrench (Nobel)DIO Screw Guide TapDIO Screw RemoveDIO Sinus Approach Bone CondenserDIO Sinus Approach Depth GaugeDIO Sinus Approach StopperDIO Sinus ElavatorDIo Slot DriverDIO Solid Abutment DriverDIO Square HandleDIO Square Hex Screw DriverDIO Square WrenchDIO Tap AdapterDIo Torque WrenchDIO Water Membrane LifterDIOnavi. Drill TubeDIOnavi. Metal Needle Tip Extra LongDIonavi. Metal Needle Tip LongDIonavi. Metal Needle Tip ShortDIOnavi. StopperDouble Depth GaugeFTN Depth GaugeFTN Fixture DriverFTN Fixture Mount DriverPeriosteal ElevatorProtem Fixtrure Driver(Ratchet)Protem Fixture DriverProtem Fixture Driver AssyProtem Fixture Driver(Machine)Protem StopperProtem Stopper Holder(2mm)Protem Stopper Holder(4mm)Reverse TweezerSinus Membrane Detach toolStopper(Sinus Approach)UF(II) Abutment CarrierUF(II) H-Scan Body JigUF(II) Internal Depth GaugeUF(II) Internal Fixture DriverUF(II) Internal Fixture Mount DriverUF(II) Multiunit Angled Abutmeng JigUF(II) Narrow Fixture Driver Contra AngleUF(II) Narrow Fixture Driver Ratchet WrenchUF(II) narrow Jig CylinderUF(II) Narrow Solid Abutment DriverUF(II) Ratchet Screw Driver1.2 Hex Driver | 2022 |
| Handpiece and Cord Foot ControllerEBW · Class 1 | — | Lister | Implant AirSURGICUBE | 2022 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | Wax Denture | 2018 |
| All Precision AttachmentEGG · Class 1 | — | Lister | OT CAP | 2013 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Lister | Wax Denture | 2019 |
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Maker | DIOnavi. Scan Retractor Lower jawDIOnavi. Scan Retractor Lower jaw SetDIOnavi. Scan Retractor Upper jawDIOnavi. Scan Retractor Upper jaw Set | 2017 |
| Ac-Powered Direct Drive HandpieceEKX · Class 1 | Dental handpieces | Lister | DIO IDx | 2018 |
| Water-Powered HandpieceEKY · Class 1 | — | Lister | TRAUS | 2021 |
| Posterior with Metal Insert Artificial TeethELJ · Class 1 | — | Maker | DIOnavi-C&BDIOnavi-C&B FDIOnavi-C&B ZDIOnavi-High C&BDIOnavi-P. MAXVeltz-C&B | 2018 |
| Surgical Osteotome ChiselEMM · Class 1 | Dental hand instruments | Maker | DIO OsteotomeDIO Osteotome KitDIO Sinus Lift KitWave ST Osteotome | 2008 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | DIO External GuideDIO Fixture AnalogDIO H-Scan BodyDIO LOCA H-Scan BodyDIO Multi Straight Abutment HolderDIO O-RingDIO Parallel PinDIO Pick-up Impression CopingDIO Reamer PinDIO Scan Adapter 146 moreDIO Scan Adapter ScrewDIO Water Membrane LifterDIO Water Membrane Lifter BodyDIO Water Membrane Lifter TubeDIOnavi-C&BDIOnavi-C&B ZDIOnavi-SGDIOnavi. Abutment JigDIOnavi. Anchor ScrewDIonavi. Anchor sleeveDIOnavi. GuideDIOnavi. Guide (Anchor system)DIOnavi. Guide sleeveDIOnavi. Implant ConnectorDIonavi. MarkerDIOnavi. Surgical GuideDIOnavi. Surgical Guide FixDIOnavi. Surgical Guide Fix PinFinal Check PinFixture Driver(Engine)FSN Fixture MountFSN Straight Drill Stopper HolderFTN Ball Abutment AnalogFTN Conical Abutment AnalogFTN Conical Plastic CylinderFTN Fixture AnalogFTN Fixture MountFTN Fixture Mount ScrewFTN Guide PinFTN H-Scan BodyFTN Impression Coping ScrewFTN Pre-milled BarFTN Scan AdapterFTN Scan Adapter ScrewFTN Transfer Impression CopingFTN Transfer Impression Coping ScrewInitial Check PinITI Scan AdapterMulti GuiderMulti-unit SelectorMulti-unit Selector KITProtem Fixture AnalogProtem Impression CopingScrew HolderScrew Remove TipSICON Surgical KITSM Guide PinSM Pick-up Impression CopingSM Positioning GuideSM Transfer Impression CopingStraight Drill StopperSurgical GuideUF Fixture MountUF H-Scan Body ScrewUF Plastic CylinderUF(II) Abutment AnalogUF(II) Angled Parallel PinUF(II) Angled Path PinUF(II) Ball Abutment AnalogUF(II) Bar HOlder Abutment AnalogUF(II) Bar Holder Abutment BarUF(II) Bar Holder Abutment ClipUF(II) Bar Holder Abutment Clip CarrierUF(II) Bar Holder ClipUF(II) Coping ScrewUF(II) Cylinder ScanbodyUF(II) DA Protect CapUF(II) Digital Lab AnalogUF(II) Digital Lab Analog JigUF(II) Eco Bite Impression CopingUF(II) Eco Coping ScrewUF(II) Eco Digital Coping ScrewUF(II) Eco Guide PinUF(II) Eco H-Scan BodyUF(II) Eco Pickup Impression CopingUF(II) Fixture AnalogUF(II) Guide PinUF(II) H-Scan BodyUF(II) Healing CapUF(II) Healing Cap ScrewUF(II) Impression CapUF(II) Internal Cast AbutmentUF(II) Internal Excellent Plastic CopingUF(II) Internal Excellent Solid AbutmentUF(II) Internal Exellent Impression CapUF(II) Internal Fixture AnalogUF(II) Internal Fixture MountUF(II) Internal GuideUF(II) Internal Guide PinUF(II) Internal H-Scan BodyUF(II) Internal Impression CapUF(II) Internal Impression Coping ScrewUF(II) Internal Octa Abutment AnalogUF(II) Internal Pick-up Impression CopingUF(II) Internal Pick-up Impression Coping ScrewUF(II) Internal Plastic CopingUF(II) Internal Plastic CylinderUF(II) Internal Positioning CylinderUF(II) Internal Pre-Milled BarUF(II) Internal Shoulder AnalogUF(II) Internal Solid Abutment AnalogUF(II) Internal Transfer Impression CopingUF(II) Multi Cylinder ProtectorUF(II) Multi Low Post Abutment AnalogUF(II) Multi Low Post Abutment CopingUF(II) Multi Low Post Abutment HolderUF(II) Multi Low Post Cylinder ProtectorUF(II) Multi Low Post Cylinder ScanBodyUF(II) Multi Low Post Digital Lap AnalogUF(II) Multi Low Post EaStab Cylinder Semi FinalUF(II) Multi Low Post H-ScanBodyUF(II) Multi Low Post Pick-up Impression CopingUF(II) Multi Low Post Plastic CylinderUF(II) Multi Low Post Scan AdapterUF(II) Multi Low Post Transfer Impression CopingUF(II) Narrow DA Protect CapUF(II) Narrow Digital Lab AnalogUF(II) Narrow Fixture AnalogUF(II) Narrow Guide pinUF(II) Narrow H-Scan BodyUF(II) Narrow Internal GuideUF(II) Narrow Pick-up Impression CopingUF(II) Narrow Protect CapUF(II) Narrow Scan AdapterUF(II) Narrow Scan Adapter ScrewUF(II) Narrow Solid Abutment AnalogUF(II) Narrow Transfer Impression CopingUF(II) Narrow Transfer Impression Coping ScrewUF(II) Narrow Trasfer Impression CopingUF(II) Parallel PinUF(II) Path PinUF(II) Pick-up Impression CopingUF(II) Plastic CopingUF(II) Pre-Milled BarUF(II) Scan AdapterUF(II) Scan Adapter ScrewUF(II) Solid Abutment AnalogUF(II) Transfer CopingUF(II) Transfer Impression CopingUF(II) Transfer Impression Coping Screw | 2013 |
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Maker | MEDIT-i500MEDIT-i700MEDIT-i700 wirelessMEDIT-i900 | 2021 |
| Resin Denture Tooth Preformed Additively ManufacturedPZY · Class 2 | Denture resins & teeth | Maker | DIOnavi-P. MAXDIOnavi. C&BDIOnavi. C&B Z | 2020 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names DIO Corporation as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 18 Aug 2023 | K220253 | Eco Abutment, Multiunit Abutment | NHA Endosseous Dental Implant Abutment |
| 23 Mar 2021 | K210828 | DIOnavi-Denture02 | EBI Rebasing Repairing Relining Denture Resin |
| 22 Oct 2020 | K193623 | DIOnavi-Denture | EBI Rebasing Repairing Relining Denture Resin |
| 18 May 2020 | K193404 | UF(II) Bar holder abutment | NHA Endosseous Dental Implant Abutment |
| 21 Feb 2020 | K192263 | UCLA CCM Abutment | NHA Endosseous Dental Implant Abutment |
| 30 Sep 2019 | K190048 | UF(II) Anatomic abutment | NHA Endosseous Dental Implant Abutment |
| 21 Dec 2018 | K181037 | DIO CAD/CAM Abutment | NHA Endosseous Dental Implant Abutment |
| 14 Dec 2018 | K182194 | UV Active Implant System | DZE Root-Form Endosseous Implant |
| 1 Jun 2018 | K173975 | UF(II) Wide Fixture | DZE Root-Form Endosseous Implant |
| 30 Mar 2018 | K170608 | UF(II) Implant System | DZE Root-Form Endosseous Implant |
| 21 Feb 2017 | K161987 | UF(II) Narrow Implant System - Fixture, UF(II) Narrow Implant System - Suprastructure | DZE Root-Form Endosseous Implant |
| 21 May 2013 | K122519 | DIO UF HSA INTERNAL SUB-MERGED IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 21 Oct 2011 | K112746 | DIOSLIMON IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 10 Nov 2010 | K100100 | DIO STEADY EXTERNAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
Also lists devices cleared under other names
DIO Corporation lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Dio Department Dsi, Inc. (7), Saeshin Precision Co., Ltd. (2), Osstell AB (1), Dsi, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 19 Feb 2015 | K142358 | Osstell IDx | Osstell AB | EKX Ac-Powered Direct Drive Handpiece |
| 18 Dec 2012 | K123695 | TRAUS SIP10 | Saeshin Precision Co., Ltd. | EKY Water-Powered Handpiece |
| 21 Sep 2009 | K092758 | X-CUBE | Saeshin Precision Co., Ltd. | EBW Handpiece and Cord Foot Controller |
| 9 Oct 2008 | K080559 | DIO SM IMPLANT SYSTEM | Dsi, Inc. | DZE Root-Form Endosseous Implant |
| 30 May 2008 | K080129 | SECURE IMPLANT SYSTEM (2.5/3.0MM) | Dio Department Dsi, Inc. | DZE Root-Form Endosseous Implant |
| 16 May 2008 | K073070 | DIO BIOTITE-H IMPLANT SYSTEM | Dio Department Dsi, Inc. | DZE Root-Form Endosseous Implant |
| 14 May 2008 | K080128 | SM-EXTRA WIDE (RBM) IMPLANT SYSTEM | Dio Department Dsi, Inc. | DZE Root-Form Endosseous Implant |
| 15 Apr 2008 | K070570 | DIO IMPLANT SYSTEM | Dio Department Dsi, Inc. | DZE Root-Form Endosseous Implant |
| 11 Apr 2008 | K080126 | DIO PROTEM IMPLANT SYSTEM | Dio Department Dsi, Inc. | DZE Root-Form Endosseous Implant |
| 8 Nov 2007 | K070569 | SM INTERNAL./EXTERNAL IMPLANT SYSTEM | Dio Department Dsi, Inc. | DZE Root-Form Endosseous Implant |
| 1 Sep 2006 | K061797 | SM IMPLANT SYSTEMS | Dio Department Dsi, Inc. | DZE Root-Form Endosseous Implant |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DIO CorporationFDA reg. 3007126709 | Haeundae-gu Busan, South Korea | Foreign exporter, Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9089142). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.