Manufacturer registered with FDA
GNI Co., LTD
Hwaseong-si, South Korea. Lists 20 dental device types with FDA across 1 registered establishment, and holds 3 510(k) clearances as applicant.
- Device types listed
- 20
- Brands and models
- 20
- 510(k) clearances
- 32019–2021
- Markets registered in
- 47 registrations outside the US
- Establishments
- 1South Korea
510(k) clearances per year, 2007–2026
Registered in 4 markets
Where regulators' registries name GNI 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 | GNI Co., LTD | 3 clearances | 2019–2021 | Below |
| Colombia | INVIMA | Manufacturer | GNI CO., LTDGNI CO., LTD. | 4 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | GNI CO., LTD | 2 | 2018–2023 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | GNI CO., LTD | 1 | 2018–2018 | 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 GNI Co., LTD currently lists, by FDA device type, with the brand and model names on the listing.
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 GNI Co., LTD as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 12 Mar 2021 | K201410 | VENUS Bracket, ROSE Bracket | NJM Orthodontic Ceramic Bracket |
| 28 Aug 2020 | K191041 | Orthodontic Fixation Screw [Smart Anchor Miniscrew] | OAT Orthodontic Endosseous Implant |
| 15 Nov 2019 | K182672 | ROSA Bracket | NJM Orthodontic Ceramic Bracket |
Some of these clearances are listed with FDA today by another company: Tangent Technologies LLC (1), Rmo, Inc. (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| GNI Co., LTDFDA reg. 3014270297 | Hwaseong-si Gyeonggi, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10056680). 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.