AMADEO, M-UK1015 (incl. attachments and accessories)— 510(k) K213221

Substantially Equivalent

W&H Dentalwerk Buermoss GmbH

FDA 510(k) clearance K213221 for AMADEO, M-UK1015 (incl. attachments and accessories), Substantially Equivalent on 2022-05-26. Applicant: W&H Dentalwerk Buermoss GmbH.

Clearance details

Applicant: W&H Dentalwerk Buermoss GmbH
Product code: Code ERL
Advisory panel: Ear, Nose, Throat
Date received: 2021-09-29
Decision date: 2022-05-26
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.