# Gni Co., Ltd.

- Location (FDA's records): Hwaseong, KR
- FDA decisions: 3 (2019–2021): 3 510(k) clearances
- Product codes: NJM (2), OAT (1)
- Predicates its devices cite: 3 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Speed Dental Co., Ltd.: 1 (https://510kreport.com/company/speed-dental)
- Jeil Medical Corporation: 1 (https://510kreport.com/company/jeil-medical)

## Its most-cited devices
- K182672: ROSA Bracket (2019), cited by 1

## Recent decisions
- K201410: VENUS Bracket, ROSE Bracket (Mar 12, 2021)
- K191041: Orthodontic Fixation Screw [Smart Anchor Miniscrew] (Aug 28, 2020)
- K182672: ROSA Bracket (Nov 15, 2019)

Source page: https://510kreport.com/company/gni