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Gni Co., Ltd.
FDA Regulatory Profile
Summary
Total Recalls
0
510(k) Clearances
3
Inspections
0
Compliance Actions
0
Recent 510(k) Clearances
K-Number
Device
Date
K201410
VENUS Bracket, ROSE Bracket
March 12, 2021
K191041
Orthodontic Fixation Screw [Smart Anchor Miniscrew]
August 28, 2020
K182672
ROSA Bracket
November 15, 2019