510(k) K223173— Proxeo ULTRA (PB-510, PB-520 and PB-530)

Substantially Equivalent

W&H Dentalwerk Buermoss GmbH

Clearance details

Applicant: W&H Dentalwerk Buermoss GmbH
Product code: Code ELC
Advisory panel: Dental
Date received: 2022-10-11
Decision date: 2023-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buermoos, AT

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.