FDA Registration
Active
🇰🇷 South Korea
GNI Co., LTD
Reg #: 3014270297
·
FEI: 3014270297
·
Expires 2026
Products
21
Proprietary Names
12
Establishment Types
1
Classifications
21
Registration Details
- Registration Name
- GNI Co., LTD
- Registration Number
- 3014270297
- FEI Number
- 3014270297
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 63-12, Dongtancheomdansaneop 1-ro 5F, 501
- City
- Hwaseong-si Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K201410
Owner / Operator
- Firm Name
- GNI Co., LTD
- Operator Number
- 10056680
- Address
- 63-12, Dongtancheomdansaneop 1-ro 5F, 501
- City
- Hwaseong-si
- State
- Gyeonggi
- Postal Code
- 18465
- Country
- KR
- Correspondent
- Soo Woong Choi
US Agent
- Business Name
- IRC USA
- Contact Name
- Charles Mack
- Address
- 2950 E Lindrick Dr.,Chandler, Arizona USA
- City
- Chandler
- State
- AZ
- ZIP
- 85249
- Country
- US
- [email protected]
- Phone
- 931 6254938
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | NOF | Class 2 | Dental | No | 2024-09-12 |
| Pusher, Band, Orthodontic | ECS | Class 1 | Dental | No | 2020-01-07 |
| Spring, Orthodontic | ECO | Class 1 | Dental | No | 2020-01-07 |
| File, Pulp Canal, Endodontic | EKS | Class 1 | Dental | No | 2024-10-21 |
| Bracket, Ceramic, Orthodontic | NJM | Class 2 | Dental | No | 2021-03-15 |
| Band, Preformed, Orthodontic | ECM | Class 1 | Dental | No | 2018-01-04 |
| Wire, Orthodontic | DZC | Class 1 | Dental | No | 2018-01-04 |
| Tube, Orthodontic | DZD | Class 1 | Dental | No | 2018-01-04 |
| Implant, Endosseous, Orthodontic | OAT | Class 2 | Dental | No | 2020-11-04 |
| Maintainer, Space Preformed, Orthodontic | DYT | Class 1 | Dental | No | 2020-01-07 |
| Aligner, Bracket, Orthodontic | ECQ | Class 1 | Dental | No | 2020-01-07 |
| Plier, Orthodontic | JEX | Class 1 | Dental | No | 2018-01-04 |
| Band, Material, Orthodontic | DYO | Class 1 | Dental | No | 2020-01-07 |
| Clamp, Wire, Orthodontic | ECN | Class 1 | Dental | No | 2020-01-07 |
| Driver, Band, Orthodontic | ECT | Class 1 | Dental | No | 2020-01-07 |
| Instrument, Ligature Tucking, Orthodontic | ECP | Class 1 | Dental | No | 2020-01-07 |
| Setter, Band, Orthodontic | ECR | Class 1 | Dental | No | 2020-01-07 |
| Retainer, Screw Expansion, Orthodontic | DYJ | Class 1 | Dental | No | 2020-01-07 |
| Band, Elastic, Orthodontic | ECI | Class 1 | Dental | No | 2018-01-04 |
| Bracket, Metal, Orthodontic | EJF | Class 1 | Dental | No | 2018-01-04 |
| Stripper, Surgical | HRT | Class 1 | Orthopedic | No | 2018-01-04 |
Proprietary Names
3D Intraoral Scanner
GNI Ortho
Endo
VENUS Bracket, ROSE Bracket
BAND, PREFORMED
WIRE
TUBE
ROSA Bracket
PLIER
BAND, ELASTIC
ZEUS Bracket, META Bracket
STRIPPER
Establishment Types
Manufacture Medical Device