JINDELL HIGH SPPED AIR TURBINE HANDPIECE, MODELS SW, SP, SU, ETU, MU— 510(k) K062740

Substantially Equivalent

Jindell Medical Instruments Co., Ltd.

FDA 510(k) clearance K062740 for JINDELL HIGH SPPED AIR TURBINE HANDPIECE, MODELS SW, SP, SU, ETU, MU, Substantially Equivalent on 2006-11-02. Applicant: Jindell Medical Instruments Co., Ltd..

Clearance details

Applicant: Jindell Medical Instruments Co., Ltd.
Product code: Code EFB
Advisory panel: Dental
Date received: 2006-09-13
Decision date: 2006-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsin-Chu City, TW

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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.