ROTA-DENT TOOTH CLEANER— 510(k) K880589

Substantially Equivalent

Pro-Dentec

FDA 510(k) clearance K880589 for ROTA-DENT TOOTH CLEANER, Substantially Equivalent on 1988-05-11. Applicant: Pro-Dentec.

Clearance details

Applicant: Pro-Dentec
Product code: Code JEQ
Advisory panel: Dental
Date received: 1988-02-11
Decision date: 1988-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, 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.