ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIAL— 510(k) K021383

Substantially Equivalent

Agion Technologies, LLC

FDA 510(k) clearance K021383 for ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIAL, Substantially Equivalent on 2002-07-17. Applicant: Agion Technologies, LLC.

Clearance details

Applicant: Agion Technologies, LLC
Product code: Code EFW
Advisory panel: Dental
Date received: 2002-05-02
Decision date: 2002-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wakefield, MA, US

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Adverse events under product code EFW

product code EFW

Injury: 143
Malfunction: 698
Total: 841

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.