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Sign in to claim this brandLEONE SPA
US
Last updated May 23, 2026
What LEONE SPA makes
The company manufactures dental implant suprastructures designed for permanent use, including preformed components for securing dental prosthetics. It also produces orthodontic devices such as ceramic brackets, anchoring screws, and retainers, as well as extraoral headgear and face bows for orthodontic treatment. Endosteal dental implants, both two-piece screws and intramucosal types, are part of its portfolio, catering to dental restoration and alignment needs.
The portfolio includes devices classified as Class I and Class II under regulatory standards, with listings in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, adhering to applicable domestic regulatory requirements for medical devices.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Leone SPA manufacture?
Leone SPA specializes in dental devices, including permanent suprastructures for dental implants, orthodontic components like ceramic brackets and anchoring screws, and endosteal implants (both two-piece screws and intramucosal types). It also produces orthodontic retainers, extraoral headgear, and face bows, focusing on dental restoration and alignment solutions.
Where is Leone SPA based, and how does this affect its regulatory compliance?
Leone SPA is based in the United States, meaning its devices must comply with FDA regulations. The company’s portfolio includes devices classified as Class I (generally low-risk) and Class II (moderate-risk), requiring adherence to FDA requirements for manufacturing, labeling, and post-market surveillance. Its devices are also listed in the FDA’s Unique Device Identifier (UDI) database.
Which regulatory registries or databases list Leone SPA’s devices?
Leone SPA’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices in the U.S. market, ensuring transparency and traceability for regulatory and clinical purposes.
How are Leone SPA’s devices classified under regulatory standards?
Leone SPA’s devices fall into two regulatory classes: Class I (for lower-risk items like some orthodontic brackets or retainers) and Class II (for moderate-risk devices such as dental implants or anchoring screws). Classification determines the level of scrutiny, testing, and regulatory oversight required before these devices can be marketed.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 432167294
Catalogue (101)
Page 1 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Leone Spa | 110-4814-02 | FDA UDI | Class II | Active |
| Leone Spa | 126-3301-07 | FDA UDI | Class II | Active |
| Leone Spa | 126-4105-15 | FDA UDI | Class II | Active |
| Leone Spa | 121-4115-00 | FDA UDI | Class II | Active |
| Leone Spa | 126-3303-07 | FDA UDI | Class II | Active |
| Leone Spa | 126-4103-01 | FDA UDI | Class II | Active |
| Leone Spa | 126-3303-25 | FDA UDI | Class II | Active |
| Leone Spa | 001-2010-02 | FDA UDI | Class II | Active |
| Leone Spa | 126-4103-15 | FDA UDI | Class II | Active |
| Leone Spa | 123-3303-00 | FDA UDI | Class II | Active |
| Leone Spa | 002-1708P02 | FDA UDI | Class II | Active |
| Leone Spa | 126-3305-01 | FDA UDI | Class II | Active |
| Leone Spa | 000-1512-01 | FDA UDI | Class II | Active |
| Leone Spa | 126-4105-35 | FDA UDI | Class II | Active |
| Leone Spa | 001-2006-02 | FDA UDI | Class II | Active |
| Leone Spa | 000-1508-02 | FDA UDI | Class II | Active |
| Leone Spa | A0720-00 | FDA UDI | Class I | Active |
| Leone Spa | 110-4808-03 | FDA UDI | Class II | Active |
| Leone Spa | 110-4810-03 | FDA UDI | Class II | Active |
| Leone Spa | 126-4107-01 | FDA UDI | Class II | Active |
| Leone Spa | 000-1508-01 | FDA UDI | Class II | Active |
| Leone Spa | 126-3305-25 | FDA UDI | Class II | Active |
| Leone Spa | 001-0002-24 | FDA UDI | Class I | Active |
| Leone Spa | 126-3303-35 | FDA UDI | Class II | Active |
| Leone Spa | 123-4101-00 | FDA UDI | Class II | Active |
| Leone Spa | 001-2006-01 | FDA UDI | Class II | Active |
| Leone Spa | 123-4105-15 | FDA UDI | Class II | Active |
| Leone Spa | 123-3305-00 | FDA UDI | Class II | Active |
| Leone Spa | 000-2008-02 | FDA UDI | Class II | Active |
| Leone Spa | 123-3303-15 | FDA UDI | Class II | Active |
| Leone Spa | 126-3305-35 | FDA UDI | Class II | Active |
| Leone Spa | M0771-00R | FDA UDI | Class II | Active |
| Leone Spa | 126-0003-48 | FDA UDI | Class II | Active |
| Leone Spa | 000-2012-02 | FDA UDI | Class II | Active |
| Leone Spa | 121-4815-00 | FDA UDI | Class II | Active |
| Leone Spa | 002-1708P03 | FDA UDI | Class II | Active |
| Leone Spa | 123-4107-15 | FDA UDI | Class II | Active |
| Leone Spa | 002-1708P04 | FDA UDI | Class II | Active |
| Leone Spa | 126-4101-25 | FDA UDI | Class II | Active |
| Leone Spa | A0721-00 | FDA UDI | Class I | Active |
| Leone Spa | 126-4105-01 | FDA UDI | Class II | Active |
| Leone Spa | P3000-02 | FDA UDI | Class I | Active |
| Leone Spa | 126-4105-07 | FDA UDI | Class II | Active |
| Leone Spa | 126-4103-25 | FDA UDI | Class II | Active |
| Leone Spa | 121-4808-00 | FDA UDI | Class II | Active |
| Leone Spa | 132-4103-41 | FDA UDI | Class II | Active |
| Leone Spa | 110-4814-03 | FDA UDI | Class II | Active |
| Leone Spa | 001-2008-02 | FDA UDI | Class II | Active |
| Leone Spa | 123-3301-15 | FDA UDI | Class II | Active |
| Leone Spa | 000-1510-02 | FDA UDI | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Leone Spa Sesto Fiorentino Firenze · IT FEI 3001561923