GBT Machine Airflow Prophylaxis Master— 510(k) K253254

Substantially Equivalent

E.M.S Electro Medical Systems S.A

FDA 510(k) clearance K253254 for GBT Machine Airflow Prophylaxis Master, Substantially Equivalent on 2026-01-28. Applicant: E.M.S Electro Medical Systems S.A.

Clearance details

Applicant: E.M.S Electro Medical Systems S.A
Product code: Code ELC
Advisory panel: Dental
Date received: 2025-09-29
Decision date: 2026-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nyon, CH

Download summary PDF View on FDA.gov ↗

Adverse events under product code ELC

product code ELC

Malfunction: 1,255
Total: 1,255

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.