LEONE ORTHODONTIC MINI IMPLANT— 510(k) K071490

Substantially Equivalent

Leone S.P.A.

FDA 510(k) clearance K071490 for LEONE ORTHODONTIC MINI IMPLANT, Substantially Equivalent on 2008-02-22. Applicant: Leone S.P.A..

Clearance details

Applicant: Leone S.P.A.
Product code: Code OAT
Advisory panel: Dental
Date received: 2007-05-30
Decision date: 2008-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sesto, Fiorentino, IT

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Adverse events under product code OAT

product code OAT

Injury: 355
Total: 355

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.