TRAUS Air Dental Handpiece— 510(k) K221741

Substantially Equivalent

Saeshin Precision Co., Ltd.

FDA 510(k) clearance K221741 for TRAUS Air Dental Handpiece, Substantially Equivalent on 2023-02-22. Applicant: Saeshin Precision Co., Ltd..

Clearance details

Applicant: Saeshin Precision Co., Ltd.
Product code: Code EFB
Advisory panel: Dental
Date received: 2022-06-15
Decision date: 2023-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Daegu, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code EFB

product code EFB

Injury: 133
Malfunction: 562
Total: 695

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.