Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014270297

FEI Number

3014270297

Entity Name

GNI Co., LTD

City/State/Country

Hwaseong-si Gyeonggi, KR

Establishment Address

63-12, Dongtancheomdansaneop 1-ro 5F, 501, Hwaseong-si Gyeonggi 18465, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

GNI Co., LTD (Owner Number: 10056680)

Owner / Operator Contact Address

63-12, Dongtancheomdansaneop 1-ro 5F, 501, Hwaseong-si, KR-41 18465, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

3D Intraoral Scanner GNI Ortho GNI Ortho Endo VENUS Bracket, ROSE Bracket BAND, PREFORMED WIRE TUBE ROSA Bracket GNI Ortho GNI Ortho PLIER GNI Ortho GNI Ortho GNI Ortho GNI Ortho GNI Ortho GNI Ortho

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NOF	System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	Dental	Class 2	872.3661	2024-09-12
ECS	Pusher, Band, Orthodontic	Dental	Class 1	872.4565	2020-01-07
ECO	Spring, Orthodontic	Dental	Class 1	872.5410	2020-01-07
EKS	File, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2024-10-21
NJM	Bracket, Ceramic, Orthodontic	Dental	Class 2	872.5470	2021-03-15
ECM	Band, Preformed, Orthodontic	Dental	Class 1	872.5410	2018-01-04
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2018-01-04
DZD	Tube, Orthodontic	Dental	Class 1	872.5410	2018-01-04
OAT	Implant, Endosseous, Orthodontic	Dental	Class 2	872.3640	2020-11-04
NJM	Bracket, Ceramic, Orthodontic	Dental	Class 2	872.5470	2019-12-25
DYT	Maintainer, Space Preformed, Orthodontic	Dental	Class 1	872.5525	2020-01-07
ECQ	Aligner, Bracket, Orthodontic	Dental	Class 1	872.4565	2020-01-07
JEX	Plier, Orthodontic	Dental	Class 1	872.4565	2018-01-04
DYO	Band, Material, Orthodontic	Dental	Class 1	872.5410	2020-01-07
ECN	Clamp, Wire, Orthodontic	Dental	Class 1	872.5410	2020-01-07
ECT	Driver, Band, Orthodontic	Dental	Class 1	872.4565	2020-01-07
ECP	Instrument, Ligature Tucking, Orthodontic	Dental	Class 1	872.4565	2020-01-07
ECR	Setter, Band, Orthodontic	Dental	Class 1	872.4565	2020-01-07
DYJ	Retainer, Screw Expansion, Orthodontic	Dental	Class 1	872.5410	2020-01-07

Official Correspondent

Soo Woong Choi

US Agent Details

Charles Mack Business: IRC USA Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

GNI Co., LTD

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K864976	Endo Technic Corp.	SOLUSET CALCIUM DEMINERALIZING SOLUTION	1987-02-27
K180404	3M Healthcare	3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System	2018-03-16
K112640	Ormco Corp.	HYPERELASTIC WIRE	2011-11-16
K110392	Psm Medical Solutions	PSM LOMAS / BENEFIT SCREWS	2011-12-14

Similar Registrations

Registration Number	Establishment Name	Location
3045007778	CMEOS MEDICAL SCI & TECH (WUXI) CO., LTD.	Wuxi Jiangsu, CN
3015786035	TUPEL LTD	Oxford Oxfordshire, GB
3035512103	SHENZHEN SHUHE TECHNOLOGY CO., LTD	Shenzhen Guangdong, CN
3044905014	FUSSEN IMAGING CO.,LTD.	Shenzhen Guangdong, CN
3010158379	DOF INC	Seoul, KR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014270297. Last updated year: 2026. Please use registration number 3014270297 when referencing this establishment in official correspondence.