Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)— 510(k) K243280

Substantially Equivalent

W&H Dentalwerk Buermoos GmbH

FDA 510(k) clearance K243280 for Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories), Substantially Equivalent on 2025-07-03. Applicant: W&H Dentalwerk Buermoos GmbH.

Clearance details

Applicant: W&H Dentalwerk Buermoos GmbH
Product code: Code ERL
Advisory panel: Ear, Nose, Throat
Date received: 2024-10-17
Decision date: 2025-07-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buermoos, AT

Download summary PDF View on FDA.gov ↗

Adverse events under product code ERL

product code ERL

Malfunction: 11,234
Total: 11,234

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.