Leone Implant System
FDA 510(k) K050586 · Leone S.P.A.
510(k) numberK050586
Submission
- Device name
- Leone Implant System
- Applicant
- Leone S.P.A.
Irvine, CA, US - Received
- March 7, 2005
- Decision date
- February 27, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code DZE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260463 | ZEROS Dental Implant SystemDZE · Special | Zeros Co., Ltd. | 08/19/2026SE |
| K251188 | UNIQA® Dental Implants SystemDZE · Traditional | Uniqa Dental, Ltd. | 06/25/2026SE |
| K251232 | MegaGen Zygoma Dental Implant SystemDZE · Traditional | Megagen Implant Co., Ltd. | 06/18/2026SE |
| K250806 | Dental Implant SystemDZE · Traditional | A.B. Dental Devices , Ltd. | 06/18/2026SE |
| K260006 | INOSS SystemDZE · Traditional | Inosys, Inc. | 06/17/2026SE |
| K252731 | Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental ImplantDZE · Traditional | Promimic AB | 05/12/2026SE |
| K252031 | Adin Long Dental Implant SystemDZE · Traditional | Adin Dental Implant Systems , Ltd. | 03/23/2026SE |
| K253334 | ZENEX Implant System_Short (R-System)DZE · Traditional | Izenimplant Co., Ltd. | 03/16/2026SE |
| K252168 | Straumann® BLC Implants - Indication WideningDZE · Traditional | Institut Straumann AG | 03/10/2026SE |
| K253493 | Dentis SQ-SL AXEL FixtureDZE · Traditional | Dentis Co., Ltd. | 03/04/2026SE |
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Questions and answers
When was Leone Implant System cleared by the FDA?
Leone Implant System (K050586) received a 510(k) decision of Substantially Equivalent on February 27, 2006, 357 days after the submission was received.
What is the product code of K050586?
The FDA product code is DZE – Implant, Endosseous, Root-Form, a Class II (moderate risk) device regulated under 21 CFR 872.3640.