# K050586: Leone Implant System

- Pathway: 510(k) (Abbreviated)
- Applicant: Leone S.P.A.
- Decided: Feb 27, 2006 after 357 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K935544 (1995). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994037: The 4.5MM Diameter Bicon Dental Implant, Bicon, Inc. (2000) Summary page 1.
- K031055: Iti Dental Implant System, Straumann USA (2003) Summary page 1.

## Most influential descendants
- K092674: Simpler Toadstool Mini Implant (2009), 0 descendants of its own
- K070483: Leone Monoimplant for O-Ring Overdenture (2007), 0 descendants of its own

## Indications for use
The Leone Implant System is indicated for single or multiple tooth replacemen, or for mue in terminal or intermediate edentulous sites in the mandible and/or the maxilla, and for totally edentulkms arches. The system is designed to be surgically inserted in the bone structure of the mouth in order to replace missing teeth. It can work as an abutment system for partial/total prosthetic restorations or as an anchorage system for removable prosthodontics.

Source page: https://510kreport.com/device/K050586
Methodology: https://510kreport.com/methodology