Medical Device Manufacturer · KR , Hwaseong

Gni Co., Ltd. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2019
3
Total
3
Cleared
0
Denied

FDA 510(k) Regulatory Record - Gni Co., Ltd. Dental ✕

3 devices
1-3 of 3
Cleared Mar 12, 2021
VENUS Bracket, ROSE Bracket
K201410 · NJM
Dental · 288d
Cleared Aug 28, 2020
Orthodontic Fixation Screw [Smart Anchor Miniscrew]
K191041 · OAT
Dental · 497d
Cleared Nov 15, 2019
ROSA Bracket
K182672 · NJM
Dental · 415d
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