Manufacturer registered with FDA
InnoBioSurg Co.,Ltd
Daejeon, South Korea. Lists 7 dental device types with FDA across 1 registered establishment, and holds 15 510(k) clearances as applicant.
- Device types listed
- 7
- Brands and models
- 184
- 510(k) clearances
- 152015–2022
- Markets registered in
- 570 registrations outside the US
- Establishments
- 1South Korea
510(k) clearances per year, 2007–2026
Registered in 5 markets
Where regulators' registries name InnoBioSurg 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 | InnoBioSurg Co.,Ltd | 15 clearances | 2015–2022 | Below |
| Canada | Health Canada | Registration holder | INNOBIOSURG. CO., LTD | 62 | 2018–2019 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | INNOBIOSURG CO., LTD | 4 | 2013–2018 | Pure Global AI |
| China | NMPA | Registration holder | 伊诺生物科技有限公司InnoBioSurg Co., Ltd.伊诺生物科技有限公司InnoBioSurg Co.,Ltd. · 伊诺生物科技有限公司InnoBiosurg Co.,Ltd. | 3 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | INNOBIOSURG CO., LTD | 1 | 2017–2017 | 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 InnoBioSurg 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 | AMII Implant Closing ScrewAMII Implant Healing CapAMII Implant Healing Cap ScrewAMII Implant SystemCCM Abutment SystemMagic Multiunit Digital CapMagic UCLA Abutment SystemPremilled Titanium Block System | 2016 |
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | AMII Implant Closing ScrewAMII Implant Healing CapAMII Implant Healing Cap ScrewAMII Implant SystemMagic Multiunit Digital Cap | 2016 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | AMII GPS Depth DrillAMII GPS DrillAMII GPS Final DrillAMII GPS Initial DrillAMII GPS Machined Tap DrillAMII GPS Magic DrillAMII GPS Ratchet Tap DrillAMII GPS Second DrillDrill ExtensionDrill Stopper 31 moreDrill Stopper HolderGPS DrillGuide DrillMagic Depth DrillMagic DrillMagic Guide PinMagic Guide Pin SETMagic Half DrillMagic Marking DrillMagic Multiunit Abutment CarrierMagic Multiunit Abutment Impression coping Guide Pin (Pick-up type)Magic Multiunit Abutment Impression coping Guide Pin (Transfer type)Magic Short DrillMagic Sinus DrillMagic Tap BodyMagic Tap DrillMagic Tap GuideMagic Tap PinMagicore Anchor DrillMagicore GPS Break DrillPeriosteum LifterSemilunar Tissue PunchSinus DrillSurgical Guide Anchor DrillSurgical Guide Depth DrillSurgical Guide Final DrillSurgical Guide Initial DrillSurgical Guide Tap DrillTissue PunchTrephine Bur1.6 Lindemann Drill | 2011 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | Open WrenchTorque Wrench | 2015 |
| Operative Dental ExcavatorEKC · Class 1 | Dental hand instruments | Maker | IBS Spoon ExcavatorSpoon Excavator | 2015 |
| Dental Surgical ElevatorEMJ · Class 1 | Dental hand instruments | Maker | innobiosurg | 2010 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | AMII AMERICA KITAMII GPS Close SleeveAMII GPS Digital KITAMII GPS Drill TubeAMII GPS KITAMII GPS Machined Fixture DriverAMII GPS Metal SleeveAMII GPS Ratchet DriverAMII GPS Ratchet Fixture DriverAMII Implant Digital Lab Analog 115 moreAMII Implant Guide Screw (Pick-up type)AMII Implant Impression coping (Pick-up type)AMII Implant Impression coping (Transfer type)AMII Implant Impression coping Guide Pin (Transfer type)AMII Implant Lab AnalogAMII Implant Machined DriverAMII Implant Multiunit Digital Lab AnalogAMII Implant Ratchet DriverAMII Implant Scan BodyAMII Implant Scan Body ScrewAMII KITAMII Narrow KITAnchor ScrewAngled Hand LeverAngulator CarrierBone PusherBone RemoverBone Remover BodyBone Remover Drill TipBone Remover Hook TipDrill SleeveExpansion KitGuide Housing Positioner DriverGuide Housing Positioner KitGuide Screw for Magicore (Pick-up type)Guide Screw for Magicore (Transfer type)Housing StabilizerImpression Coping and AnalogImpression Coping Guide Screw (Pick-up type)Impression Coping Guide Screw (Transfer type)Machine 1.2 Hex DriverMagic Diagnosis KITMagic Drill KITMagic ExpanderMagic FC Lab AnalogMagic FC Machined DriverMagic FC Ratchet DriverMagic FC Scan BodyMagic FC Solid Abutment Impression CapMagic FC Surgical Guide KitMagic Guide KitMagic HolderMagic Holder SETMagic KitMagic LifterMagic Motion DriverMagic Motion Housing Inner ProtectorMagic Motion KitMagic Multiunit Abutment Impression coping (Pick-up type)Magic Multiunit Abutment Impression coping (Transfer type)Magic Multiunit Abutment Lab AnalogMagic Multiunit Digital CapMagic Multiunit Digital Lab AnalogMagic Narrow KITMagic Prosthetics KITMagic RulerMagic Sinus & Expansion KITMagic Sinus KitMagic Sinus LifterMagic SplitMagic Standard KITMagic TapperMagicore Digital Lab AnalogMagicore GPS Anchor ScrewMagicore GPS Anchor Screw Machined DriverMagicore GPS Guide PinMagicore GPS Sleeve DrillMagicore Impression coping (Pick-up type)Magicore Impression Coping (Transfer type, One piece type)Magicore Impression coping (Transfer type)Magicore Impression Coping Guide Pin (Transfer type)Magicore KITMagicore Lab AnalogMagicore Machined DriverMagicore Path ProbeMagicore Ratchet DriverMagicore Scan BodyMagicore Scan Body ScrewMagicore Solid Abutment Impression CapMagicore Solid Abutment Lab AnalogMagicore Surgical Guide KitMultiunit Abutment Impression Coping (Pick-up type)Multiunit Abutment Impression Coping (Transfer type)Multiunit Abutment Lab AnalogMultiunit Impression Coping Guide Screw (Pick-up type)Multiunit Impression Coping Guide Screw (Transfer type)Parallel pinPath PinPeriodontal ProbePlastic CopingPositioner AngulatorPositioner BaseRatchet DriverRemoval KITResin ProtectorScrew Abutment DriverScrew Abutment Impression (Pick-up type)Screw Abutment Impression (Transfer type)Solid Abutment DrvierSolid Abutment Lab AnalogSub hex Impression Coping (Pick-up type)Sub hex Impression Coping (Transfer type)Sub Non-hex Impression Coping (Pick-up type)Sub Non-hex Impression Coping (Transfer type)Sub/screw Abutment AnalogSurgical Guide Bone PusherSurgical Guide Machine DriverSurgical Guide Magic ExpanderSurgical Guide Magic SplitSurgical Guide Ratchet DriverSurgical Guide Sinus LifterSurgical Guide TemplateTap GuideTransfer Impression Cap1.2 Hexa Driver | 2015 |
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 InnoBioSurg Co.,Ltd as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 20 Dec 2022 | K220517 | IBS System | DZE Root-Form Endosseous Implant |
| 14 Dec 2022 | K220079 | Magicore Narrow System | DZE Root-Form Endosseous Implant |
| 15 Oct 2021 | K212517 | Magicore System | DZE Root-Form Endosseous Implant |
| 25 Aug 2021 | K203344 | Premilled Titanium Block System | NHA Endosseous Dental Implant Abutment |
| 3 Dec 2020 | K202418 | Magic UCLA Abutment System | NHA Endosseous Dental Implant Abutment |
| 23 Sep 2020 | K202479 | IBS Implant System | DZE Root-Form Endosseous Implant |
| 27 Aug 2020 | K201981 | Magicore System | DZE Root-Form Endosseous Implant |
| 15 Jul 2020 | K201621 | Magicore II System | NHA Endosseous Dental Implant Abutment |
| 9 Jun 2020 | K200753 | IBS Implant System II | NHA Endosseous Dental Implant Abutment |
| 28 Apr 2020 | K192197 | Magicore II System | DZE Root-Form Endosseous Implant |
| 16 Mar 2018 | K173120 | CCM Abutment System | NHA Endosseous Dental Implant Abutment |
| 15 Feb 2017 | K162099 | IBS Implant System II | DZE Root-Form Endosseous Implant |
| 9 May 2016 | K153350 | IBS Implant System | DZE Root-Form Endosseous Implant |
| 25 Jan 2016 | K152520 | Magicore System | DZE Root-Form Endosseous Implant |
| 23 Mar 2015 | K140806 | IBS IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| INNOBIOSURG CO., LTD.FDA reg. 3008309654 | Daejeon, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10032324). 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.