Synea Fusion Handpieces (Intensiv & Profin)— 510(k) K242179

Substantially Equivalent

W&H Dentalwerk Bürmoos GmbH

FDA 510(k) clearance K242179 for Synea Fusion Handpieces (Intensiv & Profin), Substantially Equivalent on 2025-02-28. Applicant: W&H Dentalwerk Bürmoos GmbH.

Clearance details

Applicant: W&H Dentalwerk Bürmoos GmbH
Product code: Code EFB
Advisory panel: Dental
Date received: 2024-07-25
Decision date: 2025-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buermoos, AT

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.