Data / Medical devices / South Korea / GNI Co., LTD

GNI Co., LTD: FDA-registered device maker in Hwaseong-si Gyeonggi, South Korea, 3 510(k) clearances

Name: GNI Co., LTD FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

GNI Co., LTD is registered with the FDA (registration 3014270297) in Hwaseong-si Gyeonggi, South Korea. It lists 21 device types. The FDA files 3 510(k) clearances under its listings, the newest dated March 12, 2021. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3014270297
Address: 63-12, Dongtancheomdansaneop 1-ro 5F, 501, Hwaseong-si Gyeonggi, South Korea, 18465
Owner or operator: GNI Co., LTD (10056680)
Roles: Manufacturer
First device listed: January 4, 2018
Registered through: 2026
Brand names listed: 3D Intraoral Scanner, BAND, ELASTIC, BAND, PREFORMED, Endo, GNI Ortho, PLIER, ROSA Bracket, STRIPPER and more

Devices it lists

Device	Product code	Class	Role	Source
Aligner, Bracket, Orthodontic	ECQ	1	Manufacturer	accessdata.fda.gov
Band, Elastic, Orthodontic	ECI	1	Manufacturer	accessdata.fda.gov
Band, Material, Orthodontic	DYO	1	Manufacturer	accessdata.fda.gov
Band, Preformed, Orthodontic	ECM	1	Manufacturer	accessdata.fda.gov
Bracket, Ceramic, Orthodontic	NJM	2	Manufacturer	accessdata.fda.gov
Bracket, Metal, Orthodontic	EJF	1	Manufacturer	accessdata.fda.gov
Clamp, Wire, Orthodontic	ECN	1	Manufacturer	accessdata.fda.gov
Driver, Band, Orthodontic	ECT	1	Manufacturer	accessdata.fda.gov
File, Pulp Canal, Endodontic	EKS	1	Manufacturer	accessdata.fda.gov
Implant, Endosseous, Orthodontic	OAT	2	Manufacturer	accessdata.fda.gov
Instrument, Ligature Tucking, Orthodontic	ECP	1	Manufacturer	accessdata.fda.gov
Maintainer, Space Preformed, Orthodontic	DYT	1	Manufacturer	accessdata.fda.gov
Plier, Orthodontic	JEX	1	Manufacturer	accessdata.fda.gov
Pusher, Band, Orthodontic	ECS	1	Manufacturer	accessdata.fda.gov
Retainer, Screw Expansion, Orthodontic	DYJ	1	Manufacturer	accessdata.fda.gov
Setter, Band, Orthodontic	ECR	1	Manufacturer	accessdata.fda.gov
Spring, Orthodontic	ECO	1	Manufacturer	accessdata.fda.gov
Stripper, Surgical	HRT	1	Manufacturer	accessdata.fda.gov
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	NOF	2	Manufacturer	accessdata.fda.gov
Tube, Orthodontic	DZD	1	Manufacturer	accessdata.fda.gov
Wire, Orthodontic	DZC	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
March 12, 2021	K201410	VENUS Bracket, ROSE Bracket	NJM	Substantially Equivalent	Gni Co., Ltd.	accessdata.fda.gov
August 28, 2020	K191041	Orthodontic Fixation Screw [Smart Anchor Miniscrew]	OAT	Substantially Equivalent	Gni Co., Ltd.	accessdata.fda.gov
November 15, 2019	K182672	ROSA Bracket	NJM	Substantially Equivalent	Gni Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated March 12, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.