Manufacturer registered with FDA
KJ Meditech Co., Ltd.
Gwangju, South Korea. Lists 4 dental device types with FDA across 1 registered establishment, and holds 13 510(k) clearances as applicant.
- Device types listed
- 4
- Brands and models
- 46
- 510(k) clearances
- 132006–2022
- Markets registered in
- 881 registrations outside the US
- Establishments
- 1South Korea
510(k) clearances per year, 2000–2026
Registered in 8 markets
Where regulators' registries name KJ Meditech Co., Ltd. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | KJ Meditech Co., Ltd. | 13 clearances | 2006–2022 | Below |
| European Union | EUDAMED | Manufacturer | KJ MEDITECH Co., Ltd. | 28 | — | Pure Global AI |
| Australia | TGA | Manufacturer | KJ Meditech Co Ltd | 15 | 2024–2025 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | KJ MEDITECH CO., LTD.KJ MEDITECH · KJ MEDITECH Co., Ltd · +1 | 15 | 2004–2022 | Pure Global AI |
| China | NMPA | Registration holder | 光霁梅迪泰克株式会社KJ MEDITECH CO., LTD.光霁梅迪泰克株式会社KJ Meditech Co., Ltd. · 光霁梅迪泰克株式会社 KJ MEDITECH Co.,Ltd · +2 | 11 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | KJ MEDITECH CO., LTD. | 6 | 2008–2011 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | KJ Meditech Co., Ltd. | 4 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | KJ MEDITECH Co., Ltd.KJ Meditech 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 KJ Meditech 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 | Anchor plusConical Plus Implant SystemHERO I DENTAL IMPLANT SYSTEMHERO II DENTAL IMPLANT SYSTEMHexaPLUS S OneDrill Implant SystemIS DENTAL IMPLANT SYSTEMJ2A Dental Implant SystemJ2A SLA Dental Implant SystemJ2C Dental Implant SystemJ2I IMPLANT SYSTEM 11 moreJR IMPLANT SYSTEMKeratorKJ EXTERNAL IMPLANT SYSTEMKJ Mini Implant SystemKJ Submerged SystemKJ Zirconia Implant SystemLOTA HA Dental Implant SystemLOTA SLA Dental Implant SystemNeo Anchor plusONE PLUS IMPLANT SYSTEMOSSEOFUSE DENTAL IMPLANT SYSTEM | 2011 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | Conical Plus Implant SystemHERO I DENTAL IMPLANT SYSTEMHERO II DENTAL IMPLANT SYSTEMHexaPLUS S OneDrill Implant SystemIS DENTAL IMPLANT SYSTEMJ2A Dental Implant SystemJ2A SLA Dental Implant SystemJ2C Dental Implant SystemJ2I IMPLANT SYSTEMJR IMPLANT SYSTEM 6 moreKERATORKJ EXTERNAL IMPLANT SYSTEMKJ Mini Implant SystemLOTA HA Dental Implant SystemLOTA SLA Dental Implant SystemOSSEOFUSE DENTAL IMPLANT SYSTEM | 2012 |
| Orthodontic Extraoral HeadgearDZB · Class 2 | Retainers, expanders & headgear | Maker | KJ MASK | 2011 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Dental Implant AnalogDental Implant Attachment ComponentsDental Implant Comfort CapDental Implant DriversDental Implant Impression ComponentsDental Implant RemovalDental Implant Surgical DrillsDental Osteotomes | 2012 |
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 KJ Meditech Co., Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 1 Mar 2022 | K202046 | LOTA SLA Dental Implant System and LOTA HA Dental Implant System | DZE Root-Form Endosseous Implant |
| 28 Jun 2018 | K173116 | KJ ZIRCONIA Implant System | DZE Root-Form Endosseous Implant |
| 9 Nov 2017 | K161923 | J2A SLA Dental Implant System | DZE Root-Form Endosseous Implant |
| 21 Oct 2016 | K151970 | KJ Mini Implant System | DZE Root-Form Endosseous Implant |
| 2 Apr 2015 | K150060 | J2A Dental Implant System, J2C Dental Implant System | DZE Root-Form Endosseous Implant |
| 30 Oct 2014 | K140052 | J2I IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 30 Oct 2014 | K140051 | KJ EXTERNAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 17 Jan 2013 | K121098 | HERO I DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 4 Oct 2012 | K121047 | HERO II DENTAL IMPLANT SYSTEM, IS DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 8 Aug 2012 | K112787 | KERATOR | NHA Endosseous Dental Implant Abutment |
| 14 Sep 2011 | K103810 | KJ SUBMERGED SYSTEM | DZE Root-Form Endosseous Implant |
| 9 Jun 2011 | K103019 | KJ MASK | DZB Orthodontic Extraoral Headgear |
| 31 May 2006 | K053629 | ANCHOR PLUS/NEO ANCHOR PLUS | DZE Root-Form Endosseous Implant |
Some of these clearances are listed with FDA today by another company: Daekwang Idm (1), IDOC Dental Lab (1).
Also lists devices cleared under other names
KJ Meditech 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: Osseofuse, Inc. (2), LK Consulting Group USA, Inc. (2), Dynamic Innovations, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 19 Sep 2014 | K133050 | ONE PLUS IMPLANT SYSTEM | Osseofuse, Inc. | DZE Root-Form Endosseous Implant |
| 19 Jun 2014 | K130694 | JR IMPLANT SYSTEM | LK Consulting Group USA, Inc. | DZE Root-Form Endosseous Implant |
| 21 Mar 2014 | K132144 | KERATOR | LK Consulting Group USA, Inc. | DZE Root-Form Endosseous Implant |
| 31 Oct 2013 | K131748 | OSSEOFUSE DENTAL IMPLANT SYSTEM | Osseofuse, Inc. | DZE Root-Form Endosseous Implant |
| 14 Jul 2011 | K110577 | OSSEOFUSE DENTAL IMPLANT SYSTEM | Dynamic Innovations, Inc. | DZE Root-Form Endosseous Implant |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| KJ MEDITECH CO., LTD.FDA reg. 3008959419 | Gwangju, South Korea | Contract manufacturer, Contract sterilizer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10035757). 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.