510(k) K080240— CHALLENGER/CLASSIC PUSH BUTTON HANDPIECE

Substantially Equivalent

Promident, LLC

Clearance details

Applicant: Promident, LLC
Product code: Code EFB
Advisory panel: Dental
Date received: 2008-01-31
Decision date: 2008-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New City, NY, US

Adverse events under product code EFB

product code EFB

Injury: 133
Malfunction: 562
Total: 695

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.