510(k) K143418— STRONG Dental Handpieces

Substantially Equivalent

Saeshin Precision Co., Ltd.

Clearance details

Applicant: Saeshin Precision Co., Ltd.
Product code: Code EGS
Advisory panel: Dental
Date received: 2014-11-28
Decision date: 2015-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Daegu, KR

Adverse events under product code EGS

product code EGS

Injury: 356
Malfunction: 759
Total: 1,115

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.