Manufacturer registered with FDA
TruAbutment Korea Co Ltd
Bucheon-si, South Korea. Lists 6 dental device types with FDA across 1 registered establishment.
- Device types listed
- 6
- Brands and models
- 177
- 510(k) clearances
- 0as applicant
- Markets registered in
- 410 registrations outside the US
- Establishments
- 1South Korea
Registered in 4 markets
Where regulators' registries name TruAbutment Korea 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 | TruAbutment Korea Co Ltd | 6 device types | — | Below |
| Taiwan | TFDA | Manufacturer | TruAbutment Korea Co., Ltd.TRU ABUTMENT KOREA CO., LTD | 7 | 2015–2025 | Pure Global AI |
| Australia | TGA | Manufacturer | TruAbutment Korea Co Ltd | 2 | 2019–2019 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | TRUABUTMENT KOREA CO., LTD. | 1 | 2025–2025 | 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 TruAbutment Korea 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 | AOT & T-L AbutmentTruAbutment DSTruAbutment DS, TruBaseTruBaseURIS Long Implant & AbutmentsURIS OMNI ImplantURIS Smart Path Implant System & Prosthetic | 2016 |
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | URIS Long Implant & AbutmentsURIS OMNI ImplantURIS Smart Path Implant System & Prosthetic | 2018 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | Anchor DrillBone ProfilerFinal DrillFlat DrillInitial DrillPath DrillPilot DrillPoint DrillProfile DrillReduction Bur 15 moreRound DrillSide Cut DrillSinus DrillSocket DrillStep DrillStraight DrillSurgical DrillTap DrillTapered DrillTruBolt DrillTruGUIDE Kit Point DrillTruGUIDE Kit ReamerTruGUIDE Kit Taper DrillTruGUIDE Kit Twist DrillTruGUIDE Twist Drill | 2016 |
| All Precision AttachmentEGG · Class 1 | — | Maker | T-L Cap Set | 2026 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | Base ReamerCone ReamerDirect Screw Final ReamerDirect Screw Initial ReamerDirect Screw Reamer StopperTru Reamer Kit | 2025 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Anchor DriverAnchor PinAOT Conversion Scan BodyAOT Delivery ToolAOT Digital AnalogAOT HS Cap ScrewAOT Lab AnalogAOT Plus Conversion ScanAOT Plus Digital AnalogAOT Plus Impression Screw 125 moreAOT Plus Scan BodyAOT Plus Scan Body ScrewAOT Plus Short Block Out SpaceAOT Scan BodyAOT Straight DriverASC DriverASC KitBall Abutment AnalogBall Abutment DriverBone CondenserBone Condenser HandleBurn Out CopingDepth GaugeDigital Analog ScrewDirect Abutment AnalogDrill ExtensionExtension AdapterFixation PinFixation ScrewFixture AnalogFixture Digital AnalogFixture DriverGuide PinHand AdapterHex DriverHS CapHS Cap SmallImpression CapImpression Post Pick-Up TypeImpression Post Pick-Up Type ScrewImpression Post Transfer TypeImpression Post Transfer Type ScrewioConnectioConnect KitioConnect ScrewMembrane ElevatorMembrane Elevator CarrierMembrane Elevator TubeMOD RetractorMOD Retractor HandleMOD TipMount ConnectorMulti-Unit Abut. DriverMulti-Unit Abutment AnalogMulti-Unit Burn Out CylinderMulti-Unit Conversion Scan BodyMulti-Unit Digital AnalogMulti-Unit Impression Post Pick-Up TypeMulti-Unit Impression Post Pick-Up Type ScrewMulti-Unit Impression Post Transfer TypeMulti-Unit Lab AnalogMulti-Unit Scan BodyMulti-Unit Scan Body ScrewOMNI Angled Gauge DriverOMNI Mount DriverParallel PinPath PinPylon SleeveRemoval DriverScan Body MetalScrew Removal DriverSmart Driver KitSP Scan bodySP Scan PostSquare SpannerT-L Abutment AnalogT-L Digital AnalogT-L Impression CopingT-L Scan BodyT-L Straight DriverT-MarkerT-Marker KitT-Marker ScrewTissue PunchTitanium BowlTorque WrenchTru 2-way DriverTru ASC Pro KitTru Driver HandTru Driver Hand ToolTru Driver HandpieceTru Driver RatchetTru Dual Align Base ScrewTru Dual Align Direct ScrewTru Dual Align Scan BodyTru Dual Align Scan Body KitTruBite ScopeTruBoltTruBolt Driver Hand TipTruBolt Driver HandpieceTruBolt KitTruDigital AnalogTruDigital Analog ScrewTruGUIDE Guide SleeveTruGUIDE Guide Sleeve Pushing JigTruGUIDE Guide Tissue PunchTruGUIDE KitTruLab AnalogTruScan BodyTruScan Body KitTruScan Body ScrewTruScan PostTruScan Post CapTruScan Post Cap SetTruScan Post KitTruScan Post Kit CaseTruTiming Guide KitUnigrip Screw DriverURIS All-on-X Pro KitURIS Narrow Pylon KitURIS OMNI Surgical KitURIS Prosthetic Driver KitURIS Pylon Anchor KitURIS Pylon Crestal Sinus KitURIS Pylon KitURIS Pylon Plus KitURIS Scan BodyURIS Scan Body KitURIS Scan PostURIS Scan Post Kit CaseURIS SP Surgical KitURIS Surgical Plus KitURIS Tapered Pylon KitURIS Tapered Surgical KitURIS Wide Surgical Kit | 2016 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
TruAbutment Korea 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: TruAbutment Inc. (17).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 3 Jul 2025 | K243255 | URIS Long Implant & Abutments | TruAbutment Inc. | DZE Root-Form Endosseous Implant |
| 9 Oct 2024 | K241485 | TruAbutment DS; TruBase | TruAbutment Inc. | NHA Endosseous Dental Implant Abutment |
| 29 Dec 2023 | K230438 | URIS Smart Path Implant System & Prosthetic | TruAbutment Inc. | DZE Root-Form Endosseous Implant |
| 30 Oct 2023 | K231874 | AOT & T-L Abutment | TruAbutment Inc. | NHA Endosseous Dental Implant Abutment |
| 14 Jul 2022 | K213961 | TruAbutment DS, TruBase | TruAbutment Inc. | NHA Endosseous Dental Implant Abutment |
| 15 Sep 2021 | K203649 | TruAbutment DS, TruBase | TruAbutment Inc. | NHA Endosseous Dental Implant Abutment |
| 8 Jul 2021 | K202579 | TruAbutment DS, TruBase | TruAbutment Inc. | NHA Endosseous Dental Implant Abutment |
| 4 Jun 2021 | K201842 | TruBase S | TruAbutment Inc. | NHA Endosseous Dental Implant Abutment |
| 26 Mar 2021 | K201197 | TruAbutment DS, TruBase S | TruAbutment Inc. | NHA Endosseous Dental Implant Abutment |
| 7 Oct 2020 | K200817 | URIS OMNI Narrow System & Prosthetic | TruAbutment Inc. | DZE Root-Form Endosseous Implant |
| 19 Jun 2020 | K191913 | TruAbutment DS | TruAbutment Inc. | NHA Endosseous Dental Implant Abutment |
| 29 Jan 2020 | K183106 | TruAbutment DS | TruAbutment Inc. | NHA Endosseous Dental Implant Abutment |
| 11 Sep 2018 | K171532 | TruBase S | TruAbutment Inc. | NHA Endosseous Dental Implant Abutment |
| 4 May 2018 | K172100 | URIS OMNI System | TruAbutment Inc. | DZE Root-Form Endosseous Implant |
| 23 Jan 2018 | K172304 | TruAbutment DS | TruAbutment Inc. | NHA Endosseous Dental Implant Abutment |
| 25 May 2017 | K170259 | TruAbutment DS | TruAbutment Inc. | NHA Endosseous Dental Implant Abutment |
| 20 May 2016 | K152559 | TruAbutment DS | TruAbutment Inc. | NHA Endosseous Dental Implant Abutment |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| TruAbutment Korea Co., Ltd.FDA reg. 3012422333 | Bucheon-si Gyeonggi, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10052347). 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.