BACTI-STOP TOOTHBRUSH CLEANER AND SANITIZER— 510(k) K992435

Substantially Equivalent

Azo Enterprises

FDA 510(k) clearance K992435 for BACTI-STOP TOOTHBRUSH CLEANER AND SANITIZER, Substantially Equivalent on 1999-10-15. Applicant: Azo Enterprises.

Clearance details

Applicant: Azo Enterprises
Product code: Code EFW
Advisory panel: Dental
Date received: 1999-07-22
Decision date: 1999-10-15
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.