ODONTO TOOTHBRUSH— 510(k) K852691

Substantially Equivalent

Action Hygiene Products, Inc.

FDA 510(k) clearance K852691 for ODONTO TOOTHBRUSH, Substantially Equivalent on 1985-09-27. Applicant: Action Hygiene Products, Inc..

Clearance details

Applicant: Action Hygiene Products, Inc.
Product code: Code EFW
Advisory panel: Dental
Date received: 1985-06-26
Decision date: 1985-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canada M3j 2b9, CA

Download summary PDF View on FDA.gov ↗

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.