Manufacturer registered with FDA
Leone S.P.A.
Sesto Fiorentino, Italy. Lists 25 dental device types with FDA across 1 registered establishment, and holds 4 510(k) clearances as applicant.
- Device types listed
- 25
- Brands and models
- 35
- 510(k) clearances
- 42006–2025
- Markets registered in
- 147,977 registrations outside the US
- Establishments
- 1Italy
510(k) clearances per year, 2000–2026
Registered in 14 markets
Where regulators' registries name Leone S.P.A. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Leone S.P.A. | 4 clearances | 2006–2025 | Below |
| European Union | EUDAMED | Manufacturer | LEONE S.P.A. | 7,757 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | LEONE S.P.A. | 68 | 2014–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Leone S.p.A. | 27 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Leone SPA | 26 | 2013–2026 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Leone s.p.aLeone S.p.A · LEONE s.p.a · +2 | 25 | 1998–2018 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | LEONE S.P.ALEONE S.P.A. | 24 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Leone S.p.a. | 17 | 2023–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | LEONE SPALEONE S.P.A. | 14 | 2008–2025 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Leone s.p.a. | 11 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | LEONE S.P.A. | 4 | 2006–2010 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | LEONE S.P.A. | 2 | 2006–2023 | Pure Global AI |
| China | NMPA | Registration holder | 狮子股份公司LEONE SPA | 1 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Leone S.p.A. | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Leone S.P.A. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Orthodontic Screw Expansion RetainerDYJ · Class 1 | Retainers, expanders & headgear | Maker | LEONE EXPANDERSMandibular advancersThermoplastic material | 2003 |
| Orthodontic Extraoral HeadgearDZB · Class 2 | Retainers, expanders & headgear | Maker | Orthodontic headgear, facemask/bow | 2007 |
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Maker | BIOSTELLLEOLOYLEOWIREMEMORIA | 2002 |
| Orthodontic TubeDZD · Class 1 | Orthodontic wires & bands | Maker | METAL TUBESMIM | 2003 |
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | LEONE IMPLANT SYSTEM | 2006 |
| Orthodontic Elastic BandECI · Class 1 | Orthodontic wires & bands | Maker | Elastics and ligatures | 2003 |
| Orthodontic Preformed BandECM · Class 1 | Orthodontic wires & bands | Maker | CALIBRAWEB | 2002 |
| Orthodontic Wire ClampECN · Class 1 | — | Maker | MEMORIA | 2002 |
| Orthodontic SpringECO · Class 1 | Orthodontic wires & bands | Maker | MEMORIA | 2002 |
| Orthodontic Ligature Tucking InstrumentECP · Class 1 | Dental hand instruments | Maker | Orthodontic ligature instruments | 2007 |
| Orthodontic Bracket AlignerECQ · Class 1 | Dental hand instruments | Maker | Bracket positioning gauges | 2007 |
| Orthodontic Band PusherECS · Class 1 | Dental hand instruments | Maker | Band driver and adapter | 2007 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | Dental wax | 2007 |
| Preformed ClaspEHP · Class 1 | — | Maker | PREFORMED CLASP | 2007 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | Impression Tray | 2021 |
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Maker | Lip retractor | 2007 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Maker | METAL BRACKETSMIDI DIAGONALIMINI DIAGONALI | 2002 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | BURSDRILLS | 2003 |
| Alloy Other Noble MetalEJS · Class 2 | Dental alloys | Maker | Noble alloys | 2003 |
| Operative PliersEJY · Class 1 | Dental hand instruments | Maker | Pliers, operative | 2002 |
| Operative Cutting InstrumentEKD · Class 1 | Dental hand instruments | Maker | Surgical instruments | 2007 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Maker | Orthodontic pliers and instruments | 2007 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Surgical and prosthetic accessories | 2003 |
| Orthodontic Ceramic BracketNJM · Class 2 | Orthodontic brackets | Maker | AQUA/Ceramic brackets | 2017 |
| Orthodontic Endosseous ImplantOAT · Class 2 | — | Maker | Leone Orthodontic Mini Implant | 2008 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Leone S.P.A. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 19 Jun 2025 | K242944 | Leone Orthodontic Implant TAD (Temporary Anchorage Device) | OAT Orthodontic Endosseous Implant |
| 22 Feb 2008 | K071490 | LEONE ORTHODONTIC MINI IMPLANT | OAT Orthodontic Endosseous Implant |
| 19 Apr 2007 | K070483 | LEONE MONOIMPLANT FOR O-RING OVERDENTURE | DZE Root-Form Endosseous Implant |
| 27 Feb 2006 | K050586 | LEONE IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
Also lists devices cleared under other names
Leone S.P.A. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Cdb Corporation (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 7 Aug 2009 | K091702 | CDB FLIP-SIDE-CLIP BRACKET | Cdb Corporation | NJM Orthodontic Ceramic Bracket |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| LEONE SPAFDA reg. 3001561923 | Sesto Fiorentino Firenze, Italy | Manufacturer, Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9051868). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.