BEAM BRUSH/BEAM APP— 510(k) K121165

Substantially Equivalent

Beam Technologies, LLC

FDA 510(k) clearance K121165 for BEAM BRUSH/BEAM APP, Substantially Equivalent on 2012-06-21. Applicant: Beam Technologies, LLC.

Clearance details

Applicant: Beam Technologies, LLC
Product code: Code EFW
Advisory panel: Dental
Date received: 2012-04-17
Decision date: 2012-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Louisville, KY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code EFW

product code EFW

Injury: 143
Malfunction: 698
Total: 841

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.