Manufacturer registered with FDA
ARUM DENTISTRY Co., Ltd
Yuseong-gu, South Korea. Lists 7 dental device types with FDA across 1 registered establishment, and holds 17 510(k) clearances as applicant.
- Device types listed
- 7
- Brands and models
- 172
- 510(k) clearances
- 172020–2025
- Markets registered in
- 844 registrations outside the US
- Establishments
- 1South Korea
510(k) clearances per year, 2007–2026
Registered in 8 markets
Where regulators' registries name ARUM DENTISTRY 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 | ARUM DENTISTRY Co., Ltd | 17 clearances | 2020–2025 | Below |
| European Union | EUDAMED | Manufacturer | ARUM DENTISTRY Co., Ltd. | 12 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Arum Dentistry Co Ltd | 9 | 2021–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Arum Dentistry Co., Ltd. | 9 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | ARUM DENTISTRY Co., Ltd.Arum Dentistry Co., Ltd · ARUM DENTISTRY CO., LTD. | 5 | 2020–2025 | Pure Global AI |
| Egypt | EDA | Manufacturer | ARUM DENTISTRY Co., Ltd,ARUM DENTISTRY Co., Ltd., | 4 | 2025–2026 | Pure Global AI |
| China | NMPA | Registration holder | 牙润有限公司ARUM DENTISTRY Co., Ltd.牙润有限公司 ARUM DENTISTRY Co., Ltd. | 3 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | ARUM DENTISTRY Co., Ltd. | 2 | — | 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 ARUM DENTISTRY 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 | Abutment ScrewAngled AbutmentAngled Abutment MiniCemented AbutmentCemented Abutment MiniCover ScrewDigital AbutmentHealing AbutmentMaster FixMaster Fix Screw 25 moreMulti AbutmentMulti Angled AbutmentMulti Angled Abutment ScrewMulti Angled CylinderMulti Digital CylinderMulti Healing CapMulti Master FixMulti Master Fix ScrewMulti Pre-Milled CylinderMulti Scan Healing CapMulti Scan Healing Cap ScrewMulti Temporary CylinderMulti Ti CylinderNB Fixture MiniNB I FixtureNB II FixturePre-milled BlankScan Healing AbutmentScan Healing Abutment ScrewSD Bone Level FixtureSD Tissue Level FixtureTemporary AbutmentTi-BaseTwin-ZeroTwin-Zero Screw | 2020 |
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | Abutment ScrewAngled AbutmentAngled Abutment MiniCemented AbutmentCemented Abutment MiniCover ScrewDigital AbutmentHealing AbutmentMaster FixMaster Fix Screw 22 moreMulti AbutmentMulti Angled AbutmentMulti Angled Abutment ScrewMulti Angled CylinderMulti Digital CylinderMulti Healing CapMulti Master FixMulti Master Fix ScrewMulti Pre-Milled CylinderMulti Scan Healing CapMulti Scan Healing Cap ScrewMulti Temporary CylinderMulti Ti CylinderNB Fixture MiniNB I FixtureNB II FixturePre-milled BlankScan Healing AbutmentScan Healing Abutment ScrewSD Bone Level FixtureSD Tissue Level FixtureTemporary Abutment | 2022 |
| Porcelain PowderEIH · Class 2 | Dental ceramics & zirconia | Maker | ArenaArena StarGalaxy StarMontblancTrione CTrione HTTrione HT+ | 2020 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Maker | C&B 5 HybridC&B NFH Hybrid | 2021 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | Anchor DrillBone Expander DrillBone Flattening DrillBone ProfilerCortical DrillCountersinkCrest RemoverFinal DrillFirst DrillGuide Cortical Drill 17 moreGuide CountersinkGuide Final DrillGuide Initial DrillGuide Step DrillInitial DrillLindemann Final DrillPath DrillPilot DrillPoint DrillRound BurSawSimple DrillSinus CountersinkSinus Crestal DrillSinus Lateral DrillStep DrillTrephine Drill | 2022 |
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Maker | C&B NFH Hybrid | 2024 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Abutment Remover ToolAnchor ScrewAnchor Screw Driver MachineArum Prosthetic KITBone Profiler KITBone SpreaderDepth GaugeDigital Anchor KITDigital Prosthetic KITDirection pin 58 moreDrill ExtensionDrill StopperFixture Driver MachineFixture Driver RatchetFixture Driver WrenchFixture Remover ScrewFixture Remover ToolGuide Fixture Driver MachineGuide Fixture Driver WrenchGuide PinImplant AnchorImplant Anchor BodyImplant Anchor ScrewMachine Driver ConnectorMaster Fix Prosthetic KITMini Digital KitMount PinMulti Abutment HolderNB Digital KITNB ESSENTIAL KITNB MASTER KITNB REGULAR KITParallel PinRatchet AdapterRemover ToolScrew Driver HandScrew Driver MachineScrew Driver RatchetScrew Driver WrenchScrew Hex Remover ToolScrew Hex Remover Tool GuideScrew Remover ToolSD BL Surgical KITSD Digital KITSD Multi Driver MachineSD Multi Driver WrenchSD Surgical KITSD TL Surgical KITSES 2 KITSES Bur KITSES KITSES Surgical KITSinus Drill StopperSleeveSolution KitTissue PunchTL HolderTL MountTL Mount BodyTL Mount ScrewTM MountTM Mount BodyTM Mount ScrewTorque ExtensionTorque RatchetTorque WrenchTorx Remover ToolTrial Pin | 2021 |
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 ARUM DENTISTRY Co., Ltd as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 23 Jul 2025 | K250280 | SD TL Implant System | DZE Root-Form Endosseous Implant |
| 10 Jul 2025 | K250063 | ARENA Star, Galaxy Star | EIH Porcelain Powder |
| 24 Feb 2025 | K241703 | SD Implant System | DZE Root-Form Endosseous Implant |
| 6 Jan 2025 | K242753 | SD TL Implant System | DZE Root-Form Endosseous Implant |
| 25 Nov 2024 | K242245 | Customized Abutment | NHA Endosseous Dental Implant Abutment |
| 11 Sep 2024 | K232559 | C&B NFH Hybrid | EBF Resin Tooth Shade Material |
| 5 Jun 2024 | K240603 | Ti-Base & Master Fix | NHA Endosseous Dental Implant Abutment |
| 9 May 2024 | K234112 | Customized Abutment | NHA Endosseous Dental Implant Abutment |
| 26 Apr 2024 | K240091 | NB Mini Implant System | DZE Root-Form Endosseous Implant |
| 19 Dec 2023 | K232560 | Angled Abutment | NHA Endosseous Dental Implant Abutment |
| 1 Jul 2023 | K230725 | NB Implant System | DZE Root-Form Endosseous Implant |
| 28 Apr 2023 | K223634 | Customized Abutment | NHA Endosseous Dental Implant Abutment |
| 27 Feb 2023 | K223253 | Non-Sterile Zirconia Block (ARENA Star, Mont Blanc) | EIH Porcelain Powder |
| 19 Sep 2022 | K222131 | NB 1 SA Implant System | DZE Root-Form Endosseous Implant |
| 6 Apr 2022 | K213506 | NB 1 SA Implant System | DZE Root-Form Endosseous Implant |
| 8 Dec 2021 | K210817 | C&B 5.0 Hybrid | EBG Resin Temporary Crown and Bridge |
| 9 Mar 2020 | K193425 | Pre-Milled Blank | NHA Endosseous Dental Implant Abutment |
Some of these clearances are listed with FDA today by another company: Imagine Milling Technologies, LLC (2).
Also lists devices cleared under other names
ARUM DENTISTRY 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: Fine Advanced Compound Co., Ltd. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 20 Dec 2019 | K190112 | Non-Sterile Zirconia Block | Fine Advanced Compound Co., Ltd. | EIH Porcelain Powder |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ARUM DENTISTRY Co., Ltd.FDA reg. 3015978392 | Yuseong-gu Daejeon, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10066396). 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.