TWIN POWER TURBINE HIGH SPEED AIR TURBINE DENTAL HANDPIECE— 510(k) K043498

Substantially Equivalent

J. Morita USA, Inc.

FDA 510(k) clearance K043498 for TWIN POWER TURBINE HIGH SPEED AIR TURBINE DENTAL HANDPIECE, Substantially Equivalent on 2005-02-16. Applicant: J. Morita USA, Inc..

Clearance details

Applicant: J. Morita USA, Inc.
Product code: Code EFB
Advisory panel: Dental
Date received: 2004-12-17
Decision date: 2005-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

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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.