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

Name: FDA 510(k) clearance K223173
Creator: U.S. Food and Drug Administration
Published: 2023-07-14

Substantially Equivalent

W&H Dentalwerk Buermoss GmbH

FDA 510(k) clearance K223173 for Proxeo ULTRA (PB-510, PB-520 and PB-530), Substantially Equivalent on 2023-07-14. Applicant: W&H Dentalwerk Buermoss GmbH. Device class: 2.

Clearance details

Applicant: W&H Dentalwerk Buermoss GmbH
Product code: Code ELC
Device class: Class 2
Regulation: 21 CFR 872.4850
Advisory panel: Dental
Date received: 2022-10-11
Decision date: 2023-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buermoos, AT

Download summary PDF View on FDA.gov ↗

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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.