THE SMILE MACHINE— 510(k) K891694

Substantially Equivalent

Brilliant Industries, Inc.

FDA 510(k) clearance K891694 for THE SMILE MACHINE, Substantially Equivalent on 1989-06-16. Applicant: Brilliant Industries, Inc..

Clearance details

Applicant: Brilliant Industries, Inc.
Product code: Code JEQ
Advisory panel: Dental
Date received: 1989-03-22
Decision date: 1989-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bala Cynwyd, PA, 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.