Disposable High Speed Air Turbine Handpiece— 510(k) K193264

Substantially Equivalent

Ningbo Hpdove Dental Instruments Co., Ltd.

FDA 510(k) clearance K193264 for Disposable High Speed Air Turbine Handpiece, Substantially Equivalent on 2020-08-11. Applicant: Ningbo Hpdove Dental Instruments Co., Ltd..

Clearance details

Applicant: Ningbo Hpdove Dental Instruments Co., Ltd.
Product code: Code EFB
Advisory panel: Dental
Date received: 2019-11-26
Decision date: 2020-08-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cixi City, CN

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.