Manufacturer registered with FDA
Osstem Implant Co., Ltd.
Gangseo-gu, South Korea. Lists 27 dental device types with FDA across 4 registered establishments, and holds 68 510(k) clearances as applicant.
- Device types listed
- 27
- Brands and models
- 386
- 510(k) clearances
- 682006–2026
- Markets registered in
- 151,119 registrations outside the US
- Establishments
- 4South Korea
510(k) clearances per year, 2000–2026
Registered in 15 markets
Where regulators' registries name Osstem Implant Co., Ltd. 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 | Osstem Implant Co., Ltd. | 68 clearances | 2006–2026 | Below |
| Canada | Health Canada | Registration holder | OSSTEM IMPLANT CO., LTDOSSTEM IMPLANT CO. LTD · OSSTEM IMPLANT CO., LTD. | 450 | 2011–2025 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Osstem Implant Co., Ltd.OSSTEM IMPLANT CO.,Ltd. | 191 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | OSSTEM IMPLANT CO., LTDOSSTEM IMPLANT CO., LTD. · OSSTEM IMPLANT CO. LTD · +1 | 101 | 2021–2026 | Pure Global AI |
| Colombia | INVIMA | Registration holder | OSSTEM IMPLANT CO., LTDOSSTEM IMPLANT CO., LTD. · OSSTEM IMPLANT CO LTD. | 83 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | OSSTEM Implant Co., Ltd.OSSTEM IMPLANT CO., LTD. · Osstem Implant Co., Ltd. · +2 | 80 | 2006–2025 | Pure Global AI |
| Australia | TGA | Manufacturer | Osstem Implant Co Ltd | 58 | 2014–2025 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | OSSTEM IMPLANT Co., Ltd.OSSTEM IMPLANT CO.,LTD · OSSTEM IMPLANT CO., LTD. | 56 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | OSSTEM IMPLANT Co, Ltd. | 31 | 2023–2024 | Pure Global AI |
| China | NMPA | Registration holder | 奥齿泰种植体有限责任公司Osstem Implant Co., Ltd.奥齿泰种植体有限责任公司OSSTEM IMPLANT Co., Ltd. · 奥齿泰种植体有限责任公司OSSTEM IMPLANT Co.,Ltd. · +2 | 26 | — | Pure Global AI |
| Japan | PMDA | Registration holder | ＯＳＳＴＥＭ ＩＭＰＬＡＮＴ Ｃｏ．， Ｌｔｄ． | 22 | 2011–2025 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | OSSTEM IMPLANT Co., Ltd.Osstem Implant Co., Ltd | 11 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | OSSTEM IMPLANT CO., LTD.OSSTEM IMPLANT Co., Ltd. | 7 | 2021–2024 | Pure Global AI |
| Egypt | EDA | Manufacturer | OSSTEM IMPLANT Co., Ltd.,Osstem Implant Co., Ltd, | 2 | 2026–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | OSSTEM IMPLANT Co., Ltd | 1 | — | 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 Osstem Implant Co., Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | EK Dental Implants and AbutmentsEK Multi Angled 30 Degree AbutmentET Abutment SystemET Angled AbutmentsET Combination Angled CylinderET Convertible Angled CylinderET Esthetic Low Gold CylinderET Esthetic Low Temporary CylinderET Freeform ST AbutmentsET Gold Cast Abutments 45 moreET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsET Hybrid AbutmentET Multi AbutmentsET Multi-Angled AbutmentsET Multi-NP Cast CylinderET NP-Cast AbutmentsET Prosthetic SystemET Quick Temporary AbutmentsET Rigid AbutmentsET SMARTFit AbutmentET Stud AbutmentsET Temporary AbutmentsET Transfer AbutmentsET US SS Prosthetic SystemET Ziocera AbutmentsET Ziocera Angled AbutmentsET/SS Implant SystemETIII SA Fixture System (D3.2)Healing Abutment SystemHIOSSEN implant SystemHIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)Hiossen Prosthetic SystemHiossen ProstheticsHS/HG Prosthetic SystemLink Abutment for CERECMulti Angled AbutmentMulti Angled Abutment SystemMuti Angled Abutment SystemNP-Cast Abutment SystemOssbuilderOssBuilder Healing CapOssBuilder Tenting ScrewOsstem Abutment SystemOsstem Abutment System (TS Multi Angled, US Esthetic-Low, TS Temporary)Osstem Implant SystemOSSTEM Implant System - AbutmentProsthetic SystemSB AnchorSMARTbuilder systemSS Abutment SystemSS SA Fixture SystemTS Abutment SystemTS Implant SystemUS SA Implant SystemZiocera & Convertible System | 2008 |
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | AVANA DENTAL IMPLANT SYSTEMEK Dental Implants and AbutmentsEK Multi Angled 30 Degree AbutmentEM ProvisionalEM SA Implant SystemET IV SA Dental ImplantsET/SS Implant SystemETII SA Fixture SystemETIII Nano-HA Fixture SystemETIII SA Fixture System (D3.2) 19 moreGS Fixture SystemGS III SystemGS systemHG II Fixture SystemHG II Short Fixture SystemHIOSSEN implant SystemHM SYSTEMMS SA Implant SystemMS System (Provisional)Osstem Implant SystemSS SA Fixture SystemSS Systemsuper orthodontic screwTS BA Fixture SystemTS Fixture SystemTS Implant SystemUS SA Implant SystemUS SystemUS/SS/GS System | 2008 |
| Impression MaterialELW · Class 2 | Impression materials | Maker | Hysil Impression MaterialHYSIL Impression Materials (Heavy, Mono and Bite)HySil Impression Materials (Heavy, Mono, and Bite)HySil Plus Impression MaterialsHySil Super Fast Impression Material | 2017 |
| Operative Dental UnitEIA · Class 1 | Dental chairs & operative units | Maker | K3K3 V1.2K5K5 Cart, K5 Mount, K5 Swing | 2024 |
| Bone PlateJEY · Class 2 | Maxillofacial plates & screws | Maker | OssbuilderSMARTbuilder systemSMARTbuilder System(SB1) | 2012 |
| Dental Computed Tomography X-RayOAS · Class 2 | Dental CBCT | Maker | T1 C, T1-CST2 (T2-C, T2-CS)T2 Plus (T2-C-P, T2-CS-P)T2-C. T2-CS | 2024 |
| Intraosseous Fixation ScrewDZL · Class 2 | Maxillofacial plates & screws | Maker | Bone ScrewBone TackOssBuilder Healing CapOssBuilder Tenting Screw | 2019 |
| Porcelain PowderEIH · Class 2 | Dental ceramics & zirconia | Maker | Estar-ZEstar-Z HTEstar-Z MultiEstar-Z STEstar-Z TEstar-ZE | 2021 |
| Dental Chair with Operative UnitKLC · Class 1 | Dental chairs & operative units | Maker | K5K5 Cart, K5 Mount, K5 Swing | 2024 |
| Orthodontic Endosseous ImplantOAT · Class 2 | — | Maker | OrthAnchorOrthodontic Screw | 2011 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | Anchor DrillAnchor ScrewAutoBone CollectorBone Compaction DrillBone ProfilerCAS DrillsCortical DrillsCrest RemoverDigital Lab Analog Reamer DrillDIRECT Drills 35 moreDrill Length IndicationExpansion DrillsFlattening DrillGuide DrillsGuided Initial DrillInitial DrillsLance DrillsLASK DrillsLong Shank Pilot DrillMS Implant DrillsOne485 DrillsOneCAS DrillsOneGuide DrillsOneMS DrillsOrthodontic DrillsOsstemGuide DrillsPath DrillsPerforation DrillReverse DrillsSawSaw ProtectorScrew Remover DrillsSET DrillsShaping DrillSideCut DrillsTaper DrillsThree Cutter DrillsTissue PunchesTrephine DrillsTriple Edge DrillsTwist DrillsUltra Drills122 Drills123 Drills485 Drills | 2008 |
| Dental NeedleDZM · Class 1 | Dental needles & syringes | Maker | Dental Needle 27G x 21MM | 2019 |
| Orthodontic Band DriverECT · Class 1 | Dental hand instruments | Maker | ASMDS | 2006 |
| Extraoral with Timer X-Ray UnitEHD · Class 2 | Dental X-ray units | Maker | N1 | 2024 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Maker | OSSTEM Mixing TipSUFLEX 50ML Impression Gun | 2019 |
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Maker | MalletPeriosteal ElevatorTWMW | 2006 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | AGDSC | 2006 |
| Dental Surgical ElevatorEMJ · Class 1 | Dental hand instruments | Maker | Bone SeparatorFreer ElevatorMembrane Seperator | 2022 |
| Dental Surgical CuretteEMK · Class 1 | Dental hand instruments | Maker | Gracey CuretteMetal CuretteSinus Curette | 2022 |
| Periodontic ScalerEMN · Class 1 | Dental hand instruments | Maker | Metal Scaler | 2022 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Abutment CapsAbutment DriversAbutment HolderAbutment Separate BodyAbutment Separate DriverAdapterAngled Abutment SelectorAngled Torque DriverBite Impression Coping DriversBite Indexs 124 moreBone CarriersBone CondensersBone Mill, HammerBone SpreadersBone Tack(Ejector, Holder, Handle, Protector)BowlsBurn-out CylindersCountersinkCover CapsCT Checkers (CTCHK)Defect GaugeDenture 4u GuideDepth GaugesDigital Lab Analog ScrewDrill ExtensionsDrill GuidesDriver HandlesDriver SeparatorDriversFixture DriversGuide PinsGuide ScrewGuides(Bridge, Denture, Positioning)Hand DriversHeight GaugesHexed DriversHydraulic Membrane LifterImpression CapImpression CopingsImpression GunsIndicatorKIT Steel BowlLab AnalogsLocator Torque DriverMachine Driver ConnectorMachine DriversMachine Screw DriversMembrane LiftersMountMount DriversMulti Abutment Machine DriverMulti Abutment Outer DriverMulti Angled Abutment CarrierMulti Joint HandleNarrow CapsNoMount DriversO-ring Abutment DriverO-Ring Set for Laboratory (OAO100S)Octa Abutment DriverOneGuide Anchor PinOneGuide Anchors(Bone, Fixture, Implant)OneGuide Drill HandleOneGuide Metal Sleeve, Press-in JigOneGuide Reamer (OGRD)OneJet SG (OJSG)Open WrenchesOrthodontic Screw Driver TipOrthodontic Screw Removal ToolOsstemGuide Anchor ScrewOsstemGuide MountOsteotomes(Concave, Expanding)Outer DriversParallel PinsPath CheckerPath ProbePick-up Impression CopingsPin Tools(BP Guide Distance Setup, Single Guide, SmartGuide, Trial)Plastic CapsPlastic Coping SinglePlastic CylinderPlastic Scaler ConnectorPlastic Scaler TipPolishing ProtectsPort Multi ToolPosition Jigs (TS,TS Multi,KS,SS,US Digital Lab Analog)Posterior GuideProtect CapsProtect ScrewRachet WrenchesRe-TapReamer SetsRemoval BodysRemover GuidesRemover ScrewsRemover ToolsResin MarkerRidge Split Tools(Blade Holder, Chisel)Rigid Outer DriverScan BodyScan Body Holding DriverScan PostScrew DriversScrew HoldersScrew Removal GuidesScrew Removal TipsSimple MountSimple Mount DriverSimple Mount ExtensionSingle GuidesSleevesSlot DriversSmartbrush 1Smartbrush 2SmartGuide(Single)Snap-on MountSolid Abutment DriverStopper SetsStraight Fixture Surgical TapTaper Fixture Surgical TapTemplatesTi Abutment LaboratoryTip Tools(Rigid Reamer, Abutment Removal, Bone Tack Holder)Torque ConnectorTorque Driver for Torque WrenchTorque DriversTorque ExtensionsTorque HandleTorque Ratch Insert DriversTorque WrenchesTransfer Abutment Separate Tools(Body, Driver)Transfer Impression CopingsTS Scan Healing Abutment CarrierUniversal HandleY-Connector | 2006 |
| Dental Chair without Operative UnitNRU · Class 1 | Dental chairs & operative units | Maker | K3 - Chair onlyK3-Chair only | 2024 |
| Fixture Mount KitNYE · Class 1 | Implant instruments & surgical kits | Maker | ADVANCED KIT (HAK)Assist KITBone Compaction KITBone Screw KITBone Spreader KITCrestal Approach Sinus (CAS) KitCUSTOM KITDenture 4U KitDr.Cho's Instrument KitEFR Full KIT 60 moreEFR KITEM KitESR Full KITESR FULL KIT COMPONENTESR KITESSET KITGBR KitHANARO KIT (HSK)HM KIT (HIOSSEN MS KIT)IM-Cure Kit SetLateral Approach Sinus (LAS) KITLateral Approach Sinus (LAS) KIT PLUSNEW HANARO KIT (HKA)NEW Prosthetic KITOne Day KITOne485 KITOneArch KITOneArch Scan Body KitOneCAS KITOneGuide Accessory KITOneGuide KITOneGuide KIT CASE UPPER PLATEOneGuide Training KITOneMS KITOnePositioning KITORP KITOrtho KITOssBuilder KitOsstem Basic Instrument KitOsstemGuide KITOsteo KitOsteotome KitParallel Guide Advanced KITPositioning Guide FULL KitPositioning Guide KitProsthetic Kit Case LowProsthetic Kit Case MiddleProsthetic Kit Case UpperProsthetic Simple KIT (OPSK)Selection KITSimple KitSinus KITSinus Lift KitSmart builder KitSmartGuide KITSplit Kit - OffsetSplit Kit - StraightStandard KIT lowerStandard KIT UpperSURGICAL KIT FOR GSTaper KITTaper Kit CaseTaper Ultra KITUltra KIT122 Taper Full Kit122 Taper KIT122 TAPER KIT CASE MIDDLE PLAT123 KIT123 Straight Full KIT485 Kit | 2006 |
| Oral Surgery TrayPWL · Class 1 | Dental hand instruments | Maker | Hiossen Basic Instrument KITHiossen Simple Instrument KIT | 2018 |
| Intraoral X-Ray UnitEAP · Class 2 | Dental X-ray units | Lister | S2 (digital intra-oral X-ray sensor) | 2026 |
| Animal Source Bone Grafting MaterialNPM · Class 2 | Bone grafts & membranes | Maker | A-Graft | 2024 |
| Intraoral CameraQJK · Class 2 | Intraoral cameras | Maker | SNAP Wired, SNAP Wireless | 2024 |
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 Osstem Implant Co., Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 4 Mar 2026 | K251434 | Healing Abutment System | NHA Endosseous Dental Implant Abutment |
| 13 Aug 2025 | K251569 | Bone Screw | DZL Intraosseous Fixation Screw |
| 20 Nov 2024 | K242521 | Estar-ZE | EIH Porcelain Powder |
| 6 Sep 2024 | K233806 | T2 Plus | OAS Dental Computed Tomography X-Ray |
| 20 Feb 2024 | K233194 | TS Abutment System | NHA Endosseous Dental Implant Abutment |
| 5 Dec 2023 | K232220 | SS Abutment System | NHA Endosseous Dental Implant Abutment |
| 28 Nov 2023 | K232012 | N1 | EHD Extraoral with Timer X-Ray Unit |
| 23 Sep 2023 | K222778 | Osstem Implant System | DZE Root-Form Endosseous Implant |
| 8 Sep 2022 | K221684 | Osstem Abutment System | NHA Endosseous Dental Implant Abutment |
| 21 Sep 2021 | K212303 | T2 | OAS Dental Computed Tomography X-Ray |
| 2 Jul 2021 | K210097 | Estar-Z | EIH Porcelain Powder |
| 18 Mar 2021 | K210041 | HySil Plus Impression Materials | ELW Impression Material |
| 30 Jan 2020 | K192941 | HySil Super Fast Impression Materials | ELW Impression Material |
| 4 Sep 2019 | K183347 | K3 | EIA Operative Dental Unit |
| 30 Aug 2019 | K183475 | T1-CS, T1-C | OAS Dental Computed Tomography X-Ray |
| 9 Aug 2019 | K182881 | Bone Screw, Bone Tack | DZL Intraosseous Fixation Screw |
| 12 Jul 2019 | K182091 | Osstem Abutment System | NHA Endosseous Dental Implant Abutment |
| 7 May 2019 | K181854 | OssBuilder System | DZL Intraosseous Fixation Screw |
| 13 Sep 2018 | K181236 | HySil Impression Materials | ELW Impression Material |
| 26 Mar 2018 | K172354 | OssBuilder System | JEY Bone Plate |
| 7 Jun 2017 | K170736 | HySil Impression Materials | ELW Impression Material |
| 22 May 2017 | K161689 | OSSTEM Implant System - Abutment | NHA Endosseous Dental Implant Abutment |
| 15 May 2017 | K163557 | SS SA Fixture | DZE Root-Form Endosseous Implant |
| 25 Apr 2017 | K160670 | ET US SS Prosthetic system | NHA Endosseous Dental Implant Abutment |
| 21 Apr 2017 | K163088 | TSIII BA Fixture | DZE Root-Form Endosseous Implant |
| 20 Apr 2017 | K152830 | K3 | EIA Operative Dental Unit |
| 2 Feb 2017 | K161103 | US SA Implant System | DZE Root-Form Endosseous Implant |
| 21 Dec 2016 | K161197 | Orthodontic Screw | OAT Orthodontic Endosseous Implant |
| 5 Dec 2016 | K153015 | Transfer & Angled Abutment | NHA Endosseous Dental Implant Abutment |
| 28 Oct 2016 | K160519 | Link Abutment for CEREC | NHA Endosseous Dental Implant Abutment |
| 17 Oct 2016 | K161604 | OSSTEM Implant System | DZE Root-Form Endosseous Implant |
| 21 Sep 2015 | K151262 | Hyflex Heavy, Hyflex Mono, Hyflex Light | ELW Impression Material |
| 26 Aug 2014 | K141497 | PORTABLE X-RAY SYSTEM (MODEL:EXARO,XRAY2GO) | EHD Extraoral with Timer X-Ray Unit |
| 21 Aug 2014 | K140600 | SB ANCHOR | NHA Endosseous Dental Implant Abutment |
| 20 Aug 2014 | K140507 | HIOSSEN PROSTHETIC SYSTEM | NHA Endosseous Dental Implant Abutment |
| 10 Jan 2014 | K130662 | ET PROSTHETIC SYSTEM | NHA Endosseous Dental Implant Abutment |
| 18 Sep 2013 | K130840 | SMARTBUILDER SYSTEM (SB1) | JEY Bone Plate |
| 16 May 2013 | K122124 | PORTABLE X-RAY SYSTEM | EHD Extraoral with Timer X-Ray Unit |
| 26 Apr 2013 | K123755 | MULTI ANGLED ABUTMENT | NHA Endosseous Dental Implant Abutment |
| 7 Jan 2013 | K121585 | TS IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 11 Dec 2012 | K121843 | NP-CAST ABUTMENT SYSTEM | NHA Endosseous Dental Implant Abutment |
| 29 Nov 2012 | K121995 | TS FIXTURE SYSTEM | DZE Root-Form Endosseous Implant |
| 16 Nov 2012 | K122171 | MS SA IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 3 Oct 2012 | K120951 | SMARTBUILDER SYSTEM | JEY Bone Plate |
| 10 Aug 2012 | K120847 | ET/SS IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 3 Oct 2011 | K110308 | PROSTHETIC SYSTEM | NHA Endosseous Dental Implant Abutment |
| 25 Mar 2011 | K103105 | ORTHODONTIC SCREW | OAT Orthodontic Endosseous Implant |
| 17 Aug 2010 | K100245 | HS/HG PROSTHETIC SYSTEM | NHA Endosseous Dental Implant Abutment |
| 3 Mar 2010 | K091208 | GS III SYSTEM | DZE Root-Form Endosseous Implant |
| 18 Feb 2010 | K091678 | HG II SHORT FIXTURE SYSTEM | DZE Root-Form Endosseous Implant |
| 1 May 2009 | K083633 | HS II SHORT FIXTURE SYSTEM | DZE Root-Form Endosseous Implant |
| 2 Feb 2009 | K083067 | MS SYSTEM | DZE Root-Form Endosseous Implant |
| 2 Dec 2008 | K081786 | ZIOCERA & CONVERTIBLE SYSTEM | NHA Endosseous Dental Implant Abutment |
| 14 Oct 2008 | K082213 | GS III FIXTURE SYSTEM | DZE Root-Form Endosseous Implant |
| 3 Sep 2008 | K080594 | MS SYSTEM (NARROW RIDGE) | DZE Root-Form Endosseous Implant |
| 2 Sep 2008 | K081575 | HU/HS/HG PROSTHETIC SYSTEM | NHA Endosseous Dental Implant Abutment |
| 17 Jul 2008 | K080744 | HG II FIXTURE SYSTEM | DZE Root-Form Endosseous Implant |
| 15 Jul 2008 | K081078 | NT/IT SYSTEM | DZE Root-Form Endosseous Implant |
| 7 Apr 2008 | K073465 | US/GS ULTRA WIDE SYSTEM | DZE Root-Form Endosseous Implant |
| 7 Mar 2008 | K080387 | HU II / HS II FIXTURE SYSTEM | DZE Root-Form Endosseous Implant |
| 7 Mar 2008 | K073247 | US/SS/GS SYSTEM | DZE Root-Form Endosseous Implant |
| 4 Feb 2008 | K072959 | MS SYSTEM (DENTURE) | DZE Root-Form Endosseous Implant |
| 10 Jan 2008 | K072871 | MS SYSTEM (PROVISIONAL) | DZE Root-Form Endosseous Implant |
| 6 Nov 2007 | K072896 | GS FIXTURE SYSTEM | DZE Root-Form Endosseous Implant |
| 21 Sep 2007 | K063861 | GS SYSTEM | DZE Root-Form Endosseous Implant |
| 2 Nov 2006 | K062030 | US SYSTEM | DZE Root-Form Endosseous Implant |
| 1 Nov 2006 | K062051 | SS SYSTEM | DZE Root-Form Endosseous Implant |
| 20 Oct 2006 | K062156 | SUPER ORTHODONTIC SCREW | DZE Root-Form Endosseous Implant |
Some of these clearances are listed with FDA today by another company: Hiossen Inc. (6).
Also lists devices cleared under other names
Osstem Implant Co., Ltd. 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: Hiossen Inc. (14), Osstem Implant Company., Ltd. Chair Business (1), Osstem Implant Co., Ltd. Chair Business (1), Osstem Co., Ltd. (1), Trophy Radiologie (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 29 Jan 2026 | K251427 | EK MULTI ANGLED 30 ABUTMENT | Hiossen Inc. | NHA Endosseous Dental Implant Abutment |
| 17 Jul 2025 | K251491 | K5 Cart, K5 Mount, K5 Swing | Osstem Implant Company., Ltd. Chair Business | EIA Operative Dental Unit |
| 3 Sep 2024 | K233805 | K5 | Osstem Implant Co., Ltd. Chair Business | EIA Operative Dental Unit |
| 28 Apr 2023 | K222636 | ET Abutment System | Hiossen Inc. | NHA Endosseous Dental Implant Abutment |
| 7 Jan 2022 | K203360 | EK Implants and Abutments System | Hiossen Inc. | DZE Root-Form Endosseous Implant |
| 16 Dec 2019 | K191751 | EM Provisional | Hiossen Inc. | DZE Root-Form Endosseous Implant |
| 15 Nov 2019 | K191201 | EM SA Implant System | Hiossen Inc. | DZE Root-Form Endosseous Implant |
| 21 May 2019 | K183242 | ET IV SA Dental Implants | Hiossen Inc. | DZE Root-Form Endosseous Implant |
| 11 Jan 2018 | K170421 | ET Hybrid Abutment | Hiossen Inc. | NHA Endosseous Dental Implant Abutment |
| 27 Oct 2016 | K153332 | ETIII SA Fixture System (O3.2mm) | Hiossen Inc. | DZE Root-Form Endosseous Implant |
| 3 Aug 2016 | K151542 | A-Oss | Hiossen Inc. | NPM Animal Source Bone Grafting Material |
| 21 Jul 2016 | K151626 | ET III Bio-SA Fixture System | Hiossen Inc. | DZE Root-Form Endosseous Implant |
| 12 Nov 2014 | K140934 | HIOSSEN IMPLANT SYSTEM | Hiossen Inc. | DZE Root-Form Endosseous Implant |
| 20 Dec 2013 | K132067 | MULTI ANGLED ABUTMENT SYSTEM | Hiossen Inc. | NHA Endosseous Dental Implant Abutment |
| 5 Jul 2013 | K123471 | ETII SA FIXTURE SYSTEM | Hiossen Inc. | DZE Root-Form Endosseous Implant |
| 28 Jun 2013 | K123627 | ET SMARTFIT ABUTMENT | Hiossen Inc. | NHA Endosseous Dental Implant Abutment |
| 1 Sep 2005 | K051576 | AVANA DENTAL IMPLANT SYSTEM | Osstem Co., Ltd. | DZE Root-Form Endosseous Implant |
| 19 Apr 1995 | K950532 | TROPHY RADIOLOGIE RVG PORTABLE RADIOVISIOGRAPHY | Trophy Radiologie | EAP Intraoral X-Ray Unit |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| OSSTEM IMPLANT CO., LTD.FDA reg. 3031886796 | Gangseo-gu Seoul, South Korea | Specification developer |
| OSSTEM IMPLANT CO., LTD.FDA reg. 3003394081 | Haeundae-gu Busan, South Korea | Complaint file establishment, Contract manufacturer, Foreign exporter, Manufacturer |
| OSSTEM IMPLANT CO., LTD.FDA reg. 3015332784 | SIHEUNG Gyeonggi, South Korea | Manufacturer |
| OSSTEM IMPLANT CO.,LTD.FDA reg. 3045816948 | Yeonsu-gu Incheon, South Korea | Foreign exporter, Manufacturer, Private-label distributor |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10089729, 9062743, 10095871). 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.