UFI GEL HARD C— 510(k) K030916

Substantially Equivalent

Voco GmbH

FDA 510(k) clearance K030916 for UFI GEL HARD C, Substantially Equivalent on 2003-06-19. Applicant: Voco GmbH.

Clearance details

Applicant: Voco GmbH
Product code: Code EBI
Advisory panel: Dental
Date received: 2003-03-24
Decision date: 2003-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cuxhaven, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code EBI

product code EBI

Other: 1
Total: 1

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.