Leone Implant System

Also known as: Leone, Leone Exacone

The Italian dental implant brand of Leone S.p.A., an orthodontic and implant manufacturer near Florence.

Key facts

Manufacturer	Leone S.p.A.Verified spec[1]
Country	ItalyVerified spec[1]
Manufacturer-described indication	Implant range added in the early 2000s to a long-standing orthodontic businessManufacturer-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 the implant brand of an Italian company near Florence whose main business is orthodontics; implants were added to the range in the early 2000s. Leone implants are historically associated with a self-locking Morse-taper cone connection, a friction-fit joint the company adopted well before conical connections became widespread. Because Leone is primarily an orthodontic maker, the brand name alone does not tell you whether a record refers to its implants or its orthodontic appliances.

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 Implant System	—

Clearance records for Leone Implant System 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 Implant System.

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.