ELECTRIC TOOTH-BRUSH— 510(k) K931360

Substantially Equivalent

U.S. Dentek Corp.

FDA 510(k) clearance K931360 for ELECTRIC TOOTH-BRUSH, Substantially Equivalent on 1993-07-13. Applicant: U.S. Dentek Corp..

Clearance details

Applicant: U.S. Dentek Corp.
Product code: Code JEQ
Advisory panel: Dental
Date received: 1993-03-17
Decision date: 1993-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Novato, CA, US

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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.