LEONE IMPLANT SYSTEM— 510(k) K050586

Substantially Equivalent

Leone S.P.A.

FDA 510(k) clearance K050586 for LEONE IMPLANT SYSTEM, Substantially Equivalent on 2006-02-27. Applicant: Leone S.P.A..

Clearance details

Applicant: Leone S.P.A.
Product code: Code DZE
Advisory panel: Dental
Date received: 2005-03-07
Decision date: 2006-02-27
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DZE

product code DZE

Death: 28
Injury: 3,367,041
Malfunction: 19,958
Other: 13
Total: 3,387,040

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.