ULTRASONIC TOOTHBRUSH— 510(k) K820537

Substantially Equivalent

Ultrasonic Plaque Control Laboratories

FDA 510(k) clearance K820537 for ULTRASONIC TOOTHBRUSH, Substantially Equivalent on 1982-04-27. Applicant: Ultrasonic Plaque Control Laboratories.

Clearance details

Applicant: Ultrasonic Plaque Control Laboratories
Product code: Code JEQ
Advisory panel: Dental
Date received: 1982-03-02
Decision date: 1982-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JEQ

product code JEQ

Injury: 188
Malfunction: 2,818
Total: 3,006

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.