BUTLER G.U.M. ANTIBACTERIAL TOOTHBRUSH— 510(k) K950993

Substantially Equivalent

John O. Butler

FDA 510(k) clearance K950993 for BUTLER G.U.M. ANTIBACTERIAL TOOTHBRUSH, Substantially Equivalent on 1995-06-02. Applicant: John O. Butler.

Clearance details

Applicant: John O. Butler
Product code: Code EFW
Advisory panel: Dental
Date received: 1995-03-03
Decision date: 1995-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

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.