510(k) K091065— AIR TORX, MODEL TRA-200, TRA-200-CP3, TRA-200-CP4

Substantially Equivalent

J. Morita USA, Inc.

Clearance details

Applicant: J. Morita USA, Inc.
Product code: Code EFB
Advisory panel: Dental
Date received: 2009-04-14
Decision date: 2009-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

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.