Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE)— 510(k) K162856

Substantially Equivalent

Bonart Co., Ltd.

FDA 510(k) clearance K162856 for Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE), Substantially Equivalent on 2017-07-18. Applicant: Bonart Co., Ltd..

Clearance details

Applicant: Bonart Co., Ltd.
Product code: Code EGS
Advisory panel: Dental
Date received: 2016-10-12
Decision date: 2017-07-18
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Keelung City, TW

Download summary PDF View on FDA.gov ↗

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.