Manufacturer registered with FDA
Jeil Medical Corporation
Seoul, South Korea. Lists 8 dental device types with FDA across 2 registered establishments, and holds 9 510(k) clearances as applicant.
- Device types listed
- 8
- Brands and models
- 50
- 510(k) clearances
- 92004–2026
- Markets registered in
- 12289 registrations outside the US
- Establishments
- 2South Korea
510(k) clearances per year, 2000–2026
Registered in 12 markets
Where regulators' registries name Jeil Medical Corporation 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 | Jeil Medical Corporation | 9 clearances | 2004–2026 | Below |
| Costa Rica | Ministerio de Salud | Manufacturer | Jeil Medical CorporationJEIL MEDICAL CORPORATION | 58 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | JEIL MEDICAL CORPORATION | 57 | 2007–2019 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | JEIL MEDICAL CORPORATION | 54 | 2018–2026 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | JEIL MEDICAL CORPORATION | 41 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Jeil Medical CorporationJEIL MEDICAL CORPORATION | 21 | 2006–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | Jeil Medical Corporation | 18 | 2018–2026 | Pure Global AI |
| Colombia | INVIMA | Registration holder | JEIL MEDICAL CORPORATION | 13 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Jeil Medical Corporation | 11 | — | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Jeil Medical Corporation | 8 | 2016–2016 | Pure Global AI |
| Israel | AMAR | Manufacturer | Jeil Medical Corporation | 6 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | JEIL MEDICAL CORPORATION | 2 | 2019–2019 | 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 Jeil Medical Corporation currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Bone PlateJEY · Class 2 | Maxillofacial plates & screws | Maker | Bone Fixation Screw KitGBR SystemJEIL BONE FIXATION SYSTEMLeforte MMF SystemLeforte Neuro System Bone PlateLeForte System Bone Plate & ScrewLeforte System II112-080 KIT112-081 Bone Fixation Screw Kit112-159 22 more112-159-1112-159-2112-159-3112-159-4112-160112-160-1112-160-2112-160-3112-161112-161-1112-161-2112-161-3112-162112-162-1112-162-2112-162-3112-162-4112-162-5112-163112-163-1112-163-2112-163-3 | 2006 |
| Intraosseous Fixation ScrewDZL · Class 2 | Maxillofacial plates & screws | Maker | Bone Fixation Screw KitGBR SystemJ TacJ tackJEIL BONE FIXATION SYSTEMLeforte MMF System112-080 KIT112-081 Bone Fixation Screw Kit | 2006 |
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | Dual Top | 2007 |
| Operative PliersEJY · Class 1 | Dental hand instruments | Maker | PLIERS, OPERATIVE | 2008 |
| Operative Cutting InstrumentEKD · Class 1 | Dental hand instruments | Maker | CUTTING INSTRUMENT | 2008 |
| Surgical Rongeur ForcepsEMH · Class 1 | Dental hand instruments | Maker | MRF-RTAMRF-SYMMULTIPLE MODELS: MRF-LTA | 2005 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | LINGUAL DRIVER111-AN-020 | 2007 |
| Orthodontic Endosseous ImplantOAT · Class 2 | — | Maker | Dual Top Anchor System112-070 kit | 2017 |
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 Jeil Medical Corporation as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 2 Apr 2026 | K252246 | Leforte MMF System | JEY Bone Plate |
| 23 Feb 2017 | K161335 | Dual Top Screw System | OAT Orthodontic Endosseous Implant |
| 17 Sep 2015 | K150965 | LeForte System II | JEY Bone Plate |
| 10 Jun 2015 | K143730 | GBR System | JEY Bone Plate |
| 8 Feb 2011 | K101902 | J TAC MODEL JT-MD-035, JT-MD-040, JT-MD-045, JT-CL-030 | DZL Intraosseous Fixation Screw |
| 26 Jan 2011 | K103778 | LEFORTE NEURO SYSTEM BONE PLATE | JEY Bone Plate |
| 2 Oct 2009 | K091679 | LEFORTE SYSTEM BONE PLATE | JEY Bone Plate |
| 26 May 2005 | K050669 | JEIL BONE FIXATION SYSTEM | JEY Bone Plate |
| 24 Feb 2004 | K033767 | DUAL TOP ANCHOR SYSTEM SCREWS | DZE Root-Form Endosseous Implant |
Some of these clearances are listed with FDA today by another company: Young Innovations Inc (1), Rmo, Inc. (1).
Also lists devices cleared under other names
Jeil Medical Corporation 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: Arkin Consulting Group (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 18 May 2012 | K112457 | LEFORTE SYSTEM BONE PLATE & SCREW | Arkin Consulting Group | JEY Bone Plate |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| JEIL MEDICAL CORPORATIONFDA reg. 3004049923 | Seoul, South Korea | Manufacturer |
| JEIL MEDICAL CORPORATIONFDA reg. 3014937101 | Siheung-si Gyeonggi, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9053245). 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.