EMS AIR-FLOW HANDY 2 DENTAL HANDPIECE— 510(k) K022119

Substantially Equivalent

Electro Medical Systems SA

FDA 510(k) clearance K022119 for EMS AIR-FLOW HANDY 2 DENTAL HANDPIECE, Substantially Equivalent on 2002-07-25. Applicant: Electro Medical Systems SA.

Clearance details

Applicant: Electro Medical Systems SA
Product code: Code EFB
Advisory panel: Dental
Date received: 2002-07-01
Decision date: 2002-07-25
Decision: Substantially Equivalent
Clearance type: Special
Location: North Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

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.