Orthodontic Screw— 510(k) K161197

Name: FDA 510(k) clearance K161197
Creator: U.S. Food and Drug Administration
Published: 2016-12-21

Substantially Equivalent

Osstem Implant Co., Ltd.

FDA 510(k) clearance K161197 for Orthodontic Screw, Substantially Equivalent on 2016-12-21. Applicant: Osstem Implant Co., Ltd.. Device class: 2.

Clearance details

Applicant: Osstem Implant Co., Ltd.
Product code: Code OAT
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 2016-04-28
Decision date: 2016-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Busan, KR

Download summary PDF View on FDA.gov ↗

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K222245 — ACR Screw System2023-08-21

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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.