Orthodontic Fixation Screw [Smart Anchor Miniscrew]— 510(k) K191041

Substantially Equivalent

Gni Co., Ltd.

FDA 510(k) clearance K191041 for Orthodontic Fixation Screw [Smart Anchor Miniscrew], Substantially Equivalent on 2020-08-28. Applicant: Gni Co., Ltd..

Clearance details

Applicant: Gni Co., Ltd.
Product code: Code OAT
Advisory panel: Dental
Date received: 2019-04-19
Decision date: 2020-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hwaseong, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code OAT

product code OAT

Injury: 355
Total: 355

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.