HEADS TRUE BRUSH— 510(k) K890812

Substantially Equivalent

Mcs Trading Co.

FDA 510(k) clearance K890812 for HEADS TRUE BRUSH, Substantially Equivalent on 1989-03-17. Applicant: Mcs Trading Co..

Clearance details

Applicant: Mcs Trading Co.
Product code: Code EFW
Advisory panel: Dental
Date received: 1989-02-16
Decision date: 1989-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Industry, CA, 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.