Medical Device Manufacturer · US , Irvine , CA

Leone S.P.A. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2006

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Leone S.P.A. Dental ✕

4 devices

1-4 of 4

Cleared Jun 19, 2025

Leone Orthodontic Implant TAD (Temporary Anchorage Device)

Cleared Feb 22, 2008

LEONE ORTHODONTIC MINI IMPLANT

Cleared Apr 19, 2007

LEONE MONOIMPLANT FOR O-RING OVERDENTURE

Cleared Feb 27, 2006

LEONE IMPLANT SYSTEM

Data Source

Sourced from the FDA 510(k) public files . 174,883 total devices indexed.

Last updated: Apr 27, 2026