# Leone S.P.A.

- Location (FDA's records): Sesto, Fiorentino, IT
- FDA decisions: 4 (2006–2025): 4 510(k) clearances
- Product codes: DZE (2), OAT (2)
- Predicates its devices cite: 6 (1 its own); citations of its devices by later devices: 3 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Bicon, Inc.: 1 (https://510kreport.com/company/bicon)
- Straumann USA: 1 (https://510kreport.com/company/straumann-usa)
- Psm Medical Solutions: 1 (https://510kreport.com/company/psm-medical-solutions)
- Imtec Corp.: 1 (https://510kreport.com/company/imtec)
- Dentos, Inc.: 1 (https://510kreport.com/company/dentos)

## Firms that cite its devices most
- Syntec Scientific Corp.: 1 (https://510kreport.com/company/syntec-scientific)
- Pan Global Implant: 1 (https://510kreport.com/company/pan-global-implant)

## Its most-cited devices
- K050586: Leone Implant System (2006), cited by 2
- K071490: Leone Orthodontic Mini Implant (2008), cited by 1

## Recent decisions
- K242944: Leone Orthodontic Implant TAD (Temporary Anchorage Device) (Jun 19, 2025)
- K071490: Leone Orthodontic Mini Implant (Feb 22, 2008)
- K070483: Leone Monoimplant for O-Ring Overdenture (Apr 19, 2007)
- K050586: Leone Implant System (Feb 27, 2006)

Source page: https://510kreport.com/company/leone