Manufacturer registered with FDA
Neobiotech Co., Ltd.
Wonju-si, South Korea. Lists 8 dental device types with FDA across 1 registered establishment, and holds 17 510(k) clearances as applicant.
- Device types listed
- 8
- Brands and models
- 328
- 510(k) clearances
- 172004–2024
- Markets registered in
- 141,345 registrations outside the US
- Establishments
- 1South Korea
510(k) clearances per year, 2000–2026
Registered in 14 markets
Where regulators' registries name Neobiotech 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 | Neobiotech Co., Ltd. | 17 clearances | 2004–2024 | Below |
| European Union | EUDAMED | Manufacturer | Neobiotech Co.,Ltd. | 1,038 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Neobiotech Co., Ltd. | 118 | 2021–2025 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Neobiotech Co., Ltd. | 64 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Neobiotech Co., Ltd.Neobiotech Co.,Ltd. · Neobiotech Co., Ltd · +1 | 48 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Neobiotech Co., Ltd. | 20 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Neobiotech Co., Ltd.NEOBIOTECH CO., LTD · NEOBIOTECH, CO., LTD · +2 | 18 | 2008–2025 | Pure Global AI |
| Australia | TGA | Manufacturer | Neobiotech Co Ltd | 14 | 2021–2023 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | NEOBIOTECH, Co., LTD | 8 | 2011–2015 | Pure Global AI |
| China | NMPA | Registration holder | 纽白特有限公司Neobiotech Co., Ltd.纽白特有限公司Neobiotech Co.,Ltd. | 6 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | NEOBIOTECH CO., LTD. | 6 | 2024–2025 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | NEOBIOTECH CO LTD | 2 | — | Pure Global AI |
| Japan | PMDA | Registration holder | Ｎｅｏｂｉｏｔｅｃｈ Ｃｏ．，Ｌｔｄ． | 2 | 2015–2019 | Pure Global AI |
| Israel | AMAR | Manufacturer | Neobiotech 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 Neobiotech 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 |
|---|---|---|---|---|
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | CMI implant EB SystemCMI Implant IS II activeCMI IMPLANT IS SYSTEMCMI implant IT SystemIS-III active short ImplantIS-III active SystemIS-III active System_S-narrow TypeIS-III HActive FixtureIT-III active SystemS-Mini Implant System | 2009 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | CMI implant EB SystemCMI IMPLANT IS SYSTEMIS Multi Unit Abutment SystemIS-III active SystemIS-III active System_S-narrow TypeIS-III HActive FixtureIT-III active SystemProtective Cap | 2010 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | Accessory KITAll-in-One Remover KITALX Bone TrimmerALX Margin ProfileALX MAXYALX Taper DrillALX Twist DrillALX Twist Stop DrillAutoChip MakerAutoChip Maker Set 87 moreBone ExpanderBone PlanerBone TrimmerC-Guide ReamerC-ReamerClawCortical DrillCortical TapDia MarkerEB Bone ProfilerEB&IT KITEZ-GBR KITEZ-Screw Fixation DrillEZ-Stop DrillEZ-Stop Drill KITGuide DrillIS Bone ProfilerIS Cortical DrillIS Full KITIT Margin ProfileLindemann DrillLS Round BurLS-ReamerMAXY-HardMAXY-SoftMulti ProfileNeo Core KITNeo Master KITNeo MAXY KITNeo NaviGuide KITNeo NaviGuide KIT - Narrow TypeNeo Signature KITNeo Sinusall KITNeo Surgical KITNeoGuide Bone TrimmerNeoGuide Cortical DrillNeoGuide Cortical TapNeoGuide Full TapNeoGuide Immediate Placement DrillNeoGuide Initial DrillNeoGuide Lateral Anchor Pin DrillNeoGuide Point DrillNeoGuide Single DrillNeoGuide Sinus C-ReamerNeoGuide Sinus S-ReamerNeoGuide Sinus Twist DrillNeoGuide Taper DrillNeoGuide Twist DrillPoint DrillProfile TapReverse Center DrillReverse DrillRidge Wider KITRound BurS-Mini Guide DrillS-Mini KITS-Mini Surgical TapS-Mini Twist Surgical DrillS-Narrow KITS-ReamerS-Wide KITS-Wide Multi ProfileS-Wide Tap DrillS-Wide Twist Surgical DrillSafe DiskSCA Initial DrillScrew Fixation DrillScrew Remover KIT2Side CutterSinus Crestal Approach KITSinus Lateral Approach KITSinusAll DrillSinusAll Initial DrillStop Drill KITSurgical Guide Bone PlanerSurgical Guide DrillSurgical Guide IS Fixture Profile TapSurgical Guide Lateral Anchor DrillSurgical TapSurgical Tap DrillTrephine DrillTwist Stop DrillTwist Surgical DrillVAROGuide Accessory KITVAROGuide KITVAROGuide Mini KITVAROGuide Sinus KIT | 2008 |
| Intraosseous Fixation ScrewDZL · Class 2 | Maxillofacial plates & screws | Maker | Neo GBR System | 2017 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | SAM Bite PlateSAM Partially Smile Line Plate | 2025 |
| Ac-Powered Direct Drive HandpieceEKX · Class 1 | Dental handpieces | Lister | AnyCheck IMT-100 | 2026 |
| FacebowKCR · Class 1 | Articulators & facebows | Maker | SAM Gothic ArchSmileArch M KIT | 2025 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Abutment DriverAbutment PositionerAbutment Positioner DriverAbutment Positioner SetAbutment RemoverAbutment Remover GripAbutment ScrewACM StopperALX MD Parallel PinALX Parallel Pin 197 moreALX-BT Fixture DriverALX-BT Lab AnalogALX-BT PickCap Impression BodyALX-BT PickCap Impression SetAngled DriverAqua Hose SetAqua SystemAqua TapBall Abutment DriverBall Lab AnalogBall Type DriverBone CarrierBone ChiselBone CondenserBone InserterBone SpreaderBT Scan Body SetConical GuideContra Angle ConnectorCrestal StopperCTi Contouring PlierCTi-mem Cover Cap DriverDepth GaugeDia. Indicator GuideDigital Lab AnalogDigital Lab Analog ScrewDigital Lab Analog SetDirection PinDrill ExtensionDrill HandleDrill Stop O-ringDrill Stop O-ring SETDrill StopperDriver HandleDriver HolderDriver Holder & Depth GaugeDual Hex DriverEB Fixture DriverEB Transfer Impression Coping SetExternal Direction PinExternal GuideEZ-Break DriverEZ-Cover Cap DriverEZ-Handle ConnectorEZ-Phillips Head DriverEZ-Screw Fixation Drill StopperEZ-Ti-Mem Push DriverFixture RemoverFixture Remover KITFixture Remover ScrewFixture Remover WrenchFR DriverFR Screw Hex DriverFriction DriverGuide HolderHex DriverImpression CopingInternal Direction PinInternal GuideInternal Submerged Direction PinIS Direction PinIS Encoded Healing Abutment PinIS Fixture DriverIS Impression Coping SetIS OS Lab AnalogIS Scan BodyIS Scan Body SetIT Fixture DriverIT Scan BodyIT Scan Body SetIT Transfer Impression CopingLab AnalogLab CylinderLab Cylinder SetLateral StopperMaxy ConnectorMD Parallel PinMD SpacerMD Spacer SetMini implant Impression CapMulti GaugeMulti Unit Abutment DriverMulti Unit Abutment Gold Lab CylinderMulti Unit Abutment HolderMulti Unit Abutment Lab AnalogMulti Unit Abutment Plastic Lab CylinderMulti Unit Abutment Scan BodyMulti Unit Abutment Scan Body ScrewMulti Unit SystemNeo PickCap Impression KITNeoGuide Aqua ConnectorNeoGuide Aqua Hose SetNeoGuide Bone Condenser and Aqua ConnectorNeoGuide Bone Condenser and Aqua Connector BodyNeoGuide Drill Offset StopperNeoGuide Drill StopperNeoGuide Handle GuideNeoGuide IS Fixture DriverNeoGuide IS Lab CylinderNeoGuide IS Lab Cylinder PinNeoGuide IS Lab Cylinder SetNeoGuide IT Fixture DriverNeoGuide Lateral Anchor PinNeoGuide Ratchet ConnectorNeoGuide S-Mini Fixture DriverNeoGuide Screw StopperNeoGuide Sinus Depth GaugeNeoGuide Sinus StopperNeoGuide Surgical Guide IT Lab AnalogNeoGuide Tissue PunchNeoGuide Vertical Anchor(In Bone)NeoGuide Vertical Anchor(In Bone) - ScrewNeoGuide Vertical Anchor(In Fixture)NeoGuide Vertical Anchor(In Fixture) - ScrewNeoGuide Wide Conversion SleeveOral Scan BodyOral Scan Body SetParallel PinPerfect GuidePG Hand DriverPhillips Head Screw DriverPick Cap Impression BodyPick Cap Impression ScrewPickCap Impression CapPickCap Impression PincettePickCap Impression SetPlastic CopingPlastic Impression Coping CapPlastic UCLAPower HexPower OctaPower PositionerProsthesis KITProsthetic PlanningProsthetic Planning KITQuick TightRatchetRatchet ConnectorRemover ScrewRescue Hex Driver | 2010 |
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 Neobiotech Co., Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 30 Apr 2024 | K232528 | Protective Cap | NHA Endosseous Dental Implant Abutment |
| 28 Mar 2024 | K232049 | IS-III active Short Implant | DZE Root-Form Endosseous Implant |
| 23 Jul 2021 | K210903 | IS Multi Unit Abutment System | NHA Endosseous Dental Implant Abutment |
| 14 Aug 2019 | K190849 | IS-III active System_S-narrow Type | DZE Root-Form Endosseous Implant |
| 16 Nov 2018 | K181137 | IT-III active System | DZE Root-Form Endosseous Implant |
| 3 Oct 2018 | K181138 | IS-III active System | DZE Root-Form Endosseous Implant |
| 24 Jul 2018 | K181178 | S-mini active Fixture | DZE Root-Form Endosseous Implant |
| 24 May 2018 | K173938 | IS-III HActive Fixture | DZE Root-Form Endosseous Implant |
| 10 Jan 2017 | K160991 | Neo GBR System | DZL Intraosseous Fixation Screw |
| 18 Jun 2012 | K120503 | CMI IMPLANT IS II ACTIVE | DZE Root-Form Endosseous Implant |
| 5 Apr 2012 | K113554 | CMI IMPLANT IS SYSTEM | DZE Root-Form Endosseous Implant |
| 3 Feb 2012 | K112540 | S-MINI IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 10 Jan 2012 | K111761 | NEO TITANIUM MESH, CTI-MEM | JEY Bone Plate |
| 28 Aug 2009 | K090377 | SINUS QUICK EB SYSTEM | DZE Root-Form Endosseous Implant |
| 16 Jul 2009 | K090825 | SQ IS SYSTEM | DZE Root-Form Endosseous Implant |
| 14 Jul 2009 | K090527 | SINUS QUICK IT SYSTEM | DZE Root-Form Endosseous Implant |
| 2 Nov 2004 | K042339 | NEOPLANT IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
Also lists devices cleared under other names
Neobiotech 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: DMS Co., Ltd. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 20 Feb 2019 | K180953 | AnyCheck IMT-100 | DMS Co., Ltd. | EKX Ac-Powered Direct Drive Handpiece |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| NEOBIOTECH CO., LTD.FDA reg. 3004730368 | Wonju-si Gangwon, South Korea | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9066035). 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.