Leone

Also known as: Leone S.p.A.

An Italian manufacturer near Florence, long known for orthodontic products, that has produced the Leone Implant System since 2002.

Key facts

Country	ItalyVerified spec[1]
Headquarters	Sesto Fiorentino, Florence, ItalyVerified spec[1]
Founded	Manufacturer documentation not located(The reviewed page states the location but not a founding year.)
Manufacturer-described indication	Long-established orthodontic manufacturer that extended into implantology with the Leone Implant SystemManufacturer-reported[1]
manufacturingCountry	ItalyVerified spec[2]Country of the FDA-registered device establishment, which may differ from the brand’s home country.

Overview

Leone is an Italian family firm near Florence whose main business is orthodontics; it added the Leone Implant System to its range in the early 2000s. Its implants are best known for a self-locking Morse-taper cone connection, a design lineage that predates the current fashion for conical connections elsewhere. Because Leone is primarily an orthodontic company, the brand name alone does not tell you whether a record refers to its implants or its orthodontic products.

Regulatory record

Read this before drawing conclusions. A clearance or certificate means a device may legally be sold in a market. It is not a finding that the implant performs well, and it is not a comparison against other implants. In particular, FDA "clearance" is not FDA "approval" — clearance means the FDA accepted the device as substantially equivalent to one already on the market. What these actually mean →

FDA 510(k) clearance2 records

Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.

Number	Device	Holder	Date
K070483	LEONE MONOIMPLANT FOR O-RING OVERDENTURE	Leone S.P.A.	2007-04-19
K050586	LEONE IMPLANT SYSTEM	Leone S.P.A.	2006-02-27

Other2 records

Registered device establishment in Italy. Registration records where a device is made or handled; it is not a clearance, an approval, or any assessment of the product.

Number	Device	Holder	Date
3001561923	—	LEONE SPA	—
404 device records	—	Leone	—

Clearance records for Leone were retrieved from the issuing authority's own database, not from the manufacturer's marketing material. We attribute a clearance to a brand only when the filing holder belongs to that brand's corporate family — third-party clearances for compatible components are excluded, because they belong to the company that made the component, not to Leone.

Sources

Numbers match the citations beside each claim above.

Primary sources

[1]Leone S.p.A. — Orthodontics and Implantology — Leone S.p.A.. Accessed 2026-07-22.
[2]openFDA — Device registrations and listings — US Food and Drug Administration. Accessed 2026-07-22.