Manufacturer registered with FDA
Megagen Implant Co., Ltd.
Daegu, South Korea. Lists 22 dental device types with FDA across 5 registered establishments, and holds 30 510(k) clearances as applicant.
- Device types listed
- 22
- Brands and models
- 256
- 510(k) clearances
- 302008–2026
- Markets registered in
- 181,297 registrations outside the US
- Establishments
- 5South Korea, United States
510(k) clearances per year, 2000–2026
Registered in 18 markets
Where regulators' registries name Megagen 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 | Megagen Implant Co., Ltd. | 30 clearances | 2008–2026 | Below |
| Canada | Health Canada | Registration holder | MEGAGEN IMPLANT CO., LTD.BIOLASE MG LLC. | 475 | 2004–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | BIOLASE MG LLCMegaGen Implant Co., Ltd. | 344 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | MegaGen Implant Co., Ltd.Biolase MG LLC. | 149 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | MegaGen Implant Co., Ltd. | 106 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | MegaGen Implant Co., Ltd.Biolase MG LLC | 89 | 2023–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | MEGAGEN IMPLANT CO., LTD.Biolase MG LLC | 41 | 2007–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | MegaGen Implant Co Ltd | 39 | 2016–2026 | Pure Global AI |
| China | NMPA | Registration holder | 韩国美格真种植体有限公司MegaGen Implant Co.,Ltd.韩国美格真种植体有限公司MegaGen Implant Co., Ltd. | 18 | — | Pure Global AI |
| Colombia | INVIMA | Registration holder | MEGAGEN IMPLANT CO., LTD.MEGAGEN IMPLANT | 12 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | MegaGen Implant Co.,Ltd.Megagen Implant Co,Ltd | 7 | — | Pure Global AI |
| Philippines | FDA Philippines | Manufacturer | MegaGen Implant Co., Ltd.MEGAGEN IMPLANT CO., LTD. | 6 | 2025–2025 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | MEGAGEN IMPLANT CO. LTD. | 3 | 2024–2024 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Biolase MG LLC | 3 | 2013–2026 | Pure Global AI |
| Egypt | EDA | Manufacturer | MegaGen Implant Co., Ltd, | 2 | 2026–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | BIOLASE MG LLC | 1 | 2025–2025 | Pure Global AI |
| Israel | AMAR | Manufacturer | MegaGen Implant Co., Ltd | 1 | — | Pure Global AI |
| Japan | PMDA | Registration holder | ＭｅｇａＧｅｎ Ｉｍｐｌａｎｔ Ｃｏ．， Ｌｔｄ． | 1 | 2021–2021 | 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 Megagen 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 | Abutment ScrewAdvanced Intermezzo SystemAnyOne External Implant SystemAnyOne Internal Implant SystemAnyOne Onestage Implant SystemAnyRidge Internal Implant SystemAnyRidge Octa 1 SystemARi ExCon Implant SystemBall AbutmentBLUEDIAMOND IMPLANT 17 moreBLUEDIAMOND IMPLANT SystemCover ScrewEZ Plus Implant SystemHealing AbutmentMeg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegaGen Dental Implant AbutmentMegaGen Dental Implant Systems PortfolioMegaGen Zygoma Dental Implant SystemMiNi Internal Implant SystemMulti-unit Abutment, Multi-unit Angled AbutmentRescue Internal Implant SystemScan Healing AbutmentST Internal Implant SystemTiGEN AbutmentTiGEN Abutment; PMMA Abutment and Scan Healing AbutmentXPEED AnyRidge Internal Implant SystemZrGEN Abutment | 2008 |
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | Abutment ScrewAdvanced Intermezzo SystemAnyOne External Implant SystemAnyOne Internal Implant SystemAnyOne Onestage Implant SystemAnyRidge Internal Implant SystemAnyRidge Octa 1 SystemARi ExCon Implant SystemBLUEDIAMOND IMPLANTBLUEDIAMOND IMPLANT System 12 moreExfeel Implant SystemIntermezzo Implant SystemMegaGen Dental Implant Systems PortfolioMegaGen Zygoma Dental Implant SystemMiNi Internal Implant SystemRescue External Implant SystemRescue Implant SystemRescue Internal Implant SystemST Internal Implant SystemTiGEN AbutmentXPEED AnyRidge Internal Implant SystemZrGEN Abutment | 2006 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | Auto-MaxBottom DrillCarbide Round BurCASA DrillCortical Bone DrillDense DrillDiamond DrillFinal Shaper DrillFlattening DrillFlattening Lance 11 moreInitial DrillLindermann BurLindermann DrillPoint Trephine BurReverse DrillSecond DrillShaping DrillStep DrillStopper DrillTap DrillTrephine Bur | 2008 |
| Powered Bone DrillDZI · Class 2 | Surgical drills & motors | Maker | Powered Laser Surgical Instrument | 2025 |
| All Precision AttachmentEGG · Class 1 | — | Maker | MagnetRetentive Cap | 2019 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | Impression TrayR2 Tray | 2010 |
| Oral Cavity EvacuatorEHZ · Class 1 | Suction & evacuation units | Maker | Dr. Vortex | 2020 |
| Operative Dental UnitEIA · Class 1 | Dental chairs & operative units | Maker | N2N2 (Cart B Type)N2 (Continental Type)N2 (Mount B Type) | 2023 |
| Dental Plastic Filling InstrumentEIY · Class 1 | Dental hand instruments | Maker | EZ SealEZ Seal Kit | 2012 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | DISC | 2022 |
| Dental Surgical ElevatorEMJ · Class 1 | Dental hand instruments | Maker | Core Lifter 1Core Lifter 2 | 2008 |
| Periodontic KnifeEMO · Class 1 | Dental hand instruments | Maker | Soft Tissue Harvester | 2010 |
| Bone PlateJEY · Class 2 | Maxillofacial plates & screws | Maker | i-Gen | 2014 |
| Caries Removal & Cavity Preparation Hydrokinetic Dental SystemMXF · Class 2 | — | Maker | Powered Laser Surgical Instrument | 2025 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | AnalogAnalog ScrewAnatomic Healing Abutment CaseAngle Guide ToolAXA CarrierAXA DriverAXA Scanbody for R2 PhtogramAXA Scanbody Kit for R2 PhotogramB.I.C CarrierB.I.C Guide Pin 101 moreBite Impression CapBite Impression CopingBone CarrierBone CondenserBone ProfilerBone Profiler & Bone Profiler Guide PinBone Profiler Guide Pin JigBone Splitter 1Bone Splitter 2Bur StopperBur Stopper JigBurn-Out CylinderConnection Repair ToolCrown Screw ReceiverCylinder ScrewDepth GaugeDirection IndicatorDrill ExtensionDrill StopperDrill Stopper JigEasy Crown AnalogEz Crown Impression CopingEZ DrawFinal DriverFixture DriverFlattening Drill HousingGrafting PinGuide PinHand DriverHand TapHandpiece Connectori-Pegi-Peg MountImplant RemoverImplant Remover ScrewImplant Tapping RemoverImpression CopingInsert DriverKit CaseLab AnalogLateral Sinus Graft SystemMilling ScrewMount Removal DriverMUA Scanbody for R2 PhotogramMUA Scanbody Kit for R2 PhotogramMulti Post ScrewMulti Tool, Magnetic Positioner, Housing PositionerMulti-Unit CarrierMulti-unit DriverMulti-Unit-DetectorMulti-Unit-Detector SetN2CPath FinderPlastic AbutmentPlastic CylinderPlastic Impression CopingProtective DiskRatchet ConnectorRatchet WrenchReamer Drill & Center PinRemoval DriverRemoval ScrewRetentive Cap Insertion ToolRetentive Cap Removal ToolRetractorReverse Jig ConnectorReverse ScanRight Angle DriverRP AnalogS.H.A CarrierScan AbutmentScan Abutment ScrewScan BarScan Bar ScrewScan CapScan Post CarrierScrew DriverScrew Remover Guide HolderScrew Tapping DriverSelection Guide PinShort Implant SolutionSinus ElevatorSlot DriverSocket DriverSolid Driver & Solid Post DriverSquare DriverStainless Impression CopingStainless Steel HousingStopperStopper HolderStopper Holder JigStrong WrenchSurgical GuideSurgical Kit CaseSurgical Kit Plastic CaseTi Base DetectorTi Base Detector SetTissue PunchTorque Wrench & AdaptorTrephine Stopper JigTry-In Abutment | 2005 |
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Maker | R2 PhotogramR2i3R2i5 | 2024 |
| Fixture Mount KitNYE · Class 1 | Implant instruments & surgical kits | Maker | Abutment Selection Guide KitAI Surgical KitAnchor KitAnyGuide R2 Surgical KitAnyOne Bone Profiler KitAnyOne Prosthetics KitAnyOne Stopper Drill KitAnyOne Surgical KitAnyRidge Bone Profiler KitAnyRidge Prosthetic Kit 32 moreAnyRidge Surgical KitAuto-Max KitAXA Prosthetic KitAXA Selection Guide KitBLUEDIAMOND Bone Profiler KitBLUEDIAMOND R2 GUIDE KitBonEx KitDUO Surgical KitLaboratory KitMegGyver KitMegGyver Trial KitMICAkitMILAkitMiNi KitMolar Immediate Solution KitMUA Selection Guide KitMulti Prosthetic KitPET KitR2 Narrow KitR2 ONE2 GUIDE KitR2 Sinus KitR2 Universal KitRoot Membrane KitRoot Membrane Trial KitScan Bar KitShort Drill KitSurgical KitUniversal KitZBLC KitZygomatic Surgical Kit911 Fixture kit911kit | 2025 |
| Dental Computed Tomography X-RayOAS · Class 2 | Dental CBCT | Maker | R2 STUDIO QRCT820RCT820-SC | 2022 |
| Dental Operating LightEAZ · Class 1 | Dental operating lights | Maker | Dental Light, ML200 | 2023 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Lister | Regular toothbrush, Slim toothbrushStandard toothbrush - blackStandard toothbrush - greyStandard toothbrush - whiteToothbrush HU-ENWide toothbrush | 2022 |
| Porcelain PowderEIH · Class 2 | Dental ceramics & zirconia | Lister | R2iCE II | 2025 |
| Dental Chair without Operative UnitNRU · Class 1 | Dental chairs & operative units | Maker | 2nd Assi | 2019 |
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 Megagen Implant Co., Ltd. as the applicant, including filings under its other names.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 18 Jun 2026 | K251232 | MegaGen Zygoma Dental Implant System | DZE Root-Form Endosseous Implant |
| 13 Jan 2025 | K242030 | MegaGen Dental Implant Abutment | NHA Endosseous Dental Implant Abutment |
| 27 Dec 2024 | K241972 | BLUEDIAMOND IMPLANT | DZE Root-Form Endosseous Implant |
| 18 Sep 2024 | K234142 | TiGEN Abutment, PMMA Abutment and Scan Healing Abutment | NHA Endosseous Dental Implant Abutment |
| 21 Mar 2024 | K240754 | N2 | EIA Operative Dental Unit |
| 22 Jan 2024 | K233450 | MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary Cylinder; Comfort Cap; Healing Cap; Healing Cap Screw; Milling Abutment; EZ Post Abutment; Extra EZ Post Abutment; EZ Post Cylinder; ZrGEN Abutment; Multi-unit Abutment; Multi-unit Angled Abutment; AXA Abutment (Straight); AXA Abutment (Angled); Abutment Screw; Cylinder Screw; Crown Screw | NHA Endosseous Dental Implant Abutment |
| 7 Dec 2023 | K231967 | ARi ExCon Implant System | DZE Root-Form Endosseous Implant |
| 11 Oct 2023 | K230618 | MegaGen Dental Implant Systems Portfolio - MR Conditional | DZE Root-Form Endosseous Implant |
| 18 Jul 2023 | K223339 | Bone Chamber Implant | DZE Root-Form Endosseous Implant |
| 5 Apr 2023 | K211556 | N2 | EIA Operative Dental Unit |
| 6 Jan 2023 | K211812 | BLUEDIAMOND IMPLANT, Abutment Screw | DZE Root-Form Endosseous Implant |
| 6 Dec 2022 | K222219 | R2 Studio Q/RCT820 | OAS Dental Computed Tomography X-Ray |
| 10 Nov 2022 | K220562 | TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment | NHA Endosseous Dental Implant Abutment |
| 3 Feb 2022 | K210826 | Healing Abutment, Cover Screw | NHA Endosseous Dental Implant Abutment |
| 20 Oct 2021 | K203808 | Multi-unit Abutment, Multi-unit Angled Abutment | NHA Endosseous Dental Implant Abutment |
| 28 Aug 2021 | K203554 | AnyOne External Implant System | DZE Root-Form Endosseous Implant |
| 22 Jun 2021 | K210161 | AnyOne Onestage Implant System | DZE Root-Form Endosseous Implant |
| 13 Feb 2020 | K192614 | Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment | NHA Endosseous Dental Implant Abutment |
| 14 Nov 2019 | K192347 | ST Internal Implant System | DZE Root-Form Endosseous Implant |
| 9 Oct 2019 | K182448 | AnyRidge Octa 1 Implant System | DZE Root-Form Endosseous Implant |
| 8 Oct 2019 | K191127 | Advanced Intermezzo Implant System | DZE Root-Form Endosseous Implant |
| 21 Jul 2015 | K150537 | MiNi Internal Implant System | DZE Root-Form Endosseous Implant |
| 12 Dec 2014 | K140091 | XPEED ANYRIDGE INTERNAL IMPLANT SYSYEM | DZE Root-Form Endosseous Implant |
| 25 Sep 2013 | K131289 | I-GEN | JEY Bone Plate |
| 15 Aug 2013 | K123988 | ANYONETM INTERNAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 27 Mar 2013 | K123870 | XPEED ANYRIDGE INTERNAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 4 Oct 2012 | K122231 | XPEED ANY RIDGE INTERNAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 21 Aug 2012 | K122240 | BONE PLUS BCP EAGLE EYE | LYC Synthetic Bone Grafting Material |
| 2 Jul 2010 | K090950 | BONE PLUS BCP | LYC Synthetic Bone Grafting Material |
| 15 Aug 2008 | K081302 | RESCUE EXTERNAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
Some of these clearances are listed with FDA today by another company: Digital Age Dental Laboratories, Ltd. (1).
Also lists devices cleared under other names
Megagen 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: Megagen Co., Ltd. (8), Chengdu Besmile Biotechnology Co., Ltd. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 1 Aug 2017 | K170894 | Zirconia Dental Ceramics | Chengdu Besmile Biotechnology Co., Ltd. | EIH Porcelain Powder |
| 22 Nov 2011 | K110955 | ANYRIDGE INTERNAL IMPLANT SYSTEM | Megagen Co., Ltd. | DZE Root-Form Endosseous Implant |
| 3 Feb 2011 | K101890 | BALL ABUTMENT SYSTEM | Megagen Co., Ltd. | NHA Endosseous Dental Implant Abutment |
| 11 Apr 2008 | K073058 | RESCUE INTERNAL IMPLANT SYSTEM | Megagen Co., Ltd. | DZE Root-Form Endosseous Implant |
| 18 May 2007 | K070562 | EZ PLUS IMPLANT SYSTEM | Megagen Co., Ltd. | NHA Endosseous Dental Implant Abutment |
| 2 Apr 2007 | K063216 | RESCUE INTERNAL IMPLANT SYSTEM | Megagen Co., Ltd. | DZE Root-Form Endosseous Implant |
| 19 Apr 2006 | K053353 | RESCUE IMPLANT SYSTEM | Megagen Co., Ltd. | DZE Root-Form Endosseous Implant |
| 10 Jan 2006 | K052369 | EXFEEL IMPLANT SYSTEM | Megagen Co., Ltd. | DZE Root-Form Endosseous Implant |
| 2 Sep 2005 | K051018 | INTERMEZZO IMPLANT SYSTEMS | Megagen Co., Ltd. | DZE Root-Form Endosseous Implant |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| BIOLASE MG LLCFDA reg. 2027755 | Foothill Ranch, CA, United States | Specification developer |
| BIOLASE MG LLCFDA reg. 3017125161 | Corona, CA, United States | Manufacturer |
| Megagen Implant Co., Ltd.FDA reg. 3005554774 | Daegu, South Korea | Foreign exporter, Manufacturer, Repacker / relabeler |
| MegaGen Implant Co., Ltd. (Research Laboratories)FDA reg. 3030089802 | Daegu, South Korea | Specification developer |
| MegaGen Implant Co., Ltd. (Secheon 2nd factory)FDA reg. 3030089804 | Daegu, South Korea | Manufacturer |
Other names on FDA records
Biolase MG LLC. · MegaGen Implant Co., Ltd. (Research Laboratories) · MegaGen Implant Co., Ltd. (Secheon 2nd factory)
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9067358). 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.