STRONG Dental Handpieces— 510(k) K181129

Name: FDA 510(k) clearance K181129
Creator: U.S. Food and Drug Administration
Published: 2019-01-31

Substantially Equivalent

Saeshin Precision Co., Ltd.

FDA 510(k) clearance K181129 for STRONG Dental Handpieces, Substantially Equivalent on 2019-01-31. Applicant: Saeshin Precision Co., Ltd.. Device class: 1.

Clearance details

Applicant: Saeshin Precision Co., Ltd.
Product code: Code EGS
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 2018-04-30
Decision date: 2019-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deagu, KR

Download summary PDF View on FDA.gov ↗

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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.