510(k) · Cleared
ClearedLeone Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Leone S.P.A. · DZE Implant, Endosseous, Root-Form
Cleared on Feb 27, 2006 as substantially equivalent to K994037 (Bicon, Inc., 2000) and 1 other predicate after a 357-day review. Its family tree reaches back 3 generations to 1995. 2 later devices descend from it.
- Decided
- Feb 27, 2006
- Review
- 357 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K935544 (1995). 6 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK935544 3I Standard Threaded/Self-Tapping Threaded Implants ModificationImplant Innovations International, Inc. · 1995
- 2 generations backK013570 Osseotite Dental ImplantsImplant Innovations, Inc. · 2001
- 1 generation backK031055 Iti Dental Implant SystemStraumann USA · 2003
- This deviceK050586 Leone Implant SystemLeone S.P.A. · 2006
- Descendant · cites it directly · 0 of its ownK092674 Simpler Toadstool Mini ImplantPan Global Implant · 2009
- Descendant · cites it directly · 0 of its ownK070483 Leone Monoimplant for O-Ring OverdentureLeone S.P.A. · 2007
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K935544 | 3I Standard Threaded/Self-Tapping Threaded Implants Modification | Implant Innovations International, Inc. | 1995 | — |
| −2 | K013570 | Osseotite Dental Implants | Implant Innovations, Inc. | 2001 | — |
| −1 | K031055 | Iti Dental Implant System | Straumann USA | 2003 | — |
| 0 (this device) | K050586 | Leone Implant System | Leone S.P.A. | 2006 | — |
| +1 | K092674 | Simpler Toadstool Mini Implant | Pan Global Implant | 2009 | — |
| +1 | K070483 | Leone Monoimplant for O-Ring Overdenture | Leone S.P.A. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DZE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DZE device
- #1 K211090 ZENEX Implant Systemscore 25.4 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K994037 | The 4.5MM Diameter Bicon Dental ImplantSummary page 1…plant The legally marketed device to which we are claiming equivalence [807.92(a)(3)]: Reference jDevice Na m e IManufacturer K994037 IBicon Dental Implant System Bicon, Inc K031055 ITI Dental Implant Sys… | 2000 |
| * | K031055 | Iti Dental Implant SystemSummary page 1…e jDevice Na m e IManufacturer K994037 IBicon Dental Implant System Bicon, Inc K031055 ITI Dental Implant System StraurnannUSAJ Description of the device: The Leone implant system is c… | 2003 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K092674 (Pan Global Implant, 2009) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K994037.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DZE
31in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZE
184in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZE
465,788in 2025
MAUDE reports naming product code DZE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 43 | 107 | 11 | 225 |
| 2008 | 61 | 118 | 4 | 393 |
| 2009 | 41 | 110 | 3 | 164 |
| 2010 | 34 | 162 | 3 | 360 |
| 2011 | 26 | 194 | 0 | 362 |
| 2012 | 39 | 174 | 11 | 358 |
| 2013 | 42 | 195 | 1 | 391 |
| 2014 | 36 | 265 | 7 | 1,124 |
| 2015 | 36 | 215 | 3 | 2,894 |
| 2016 | 40 | 219 | 15 | 1,116 |
| 2017 | 48 | 223 | 4 | 9,719 |
| 2018 | 41 | 200 | 4 | 12,892 |
| 2019 | 31 | 231 | 8 | 167,016 |
| 2020 | 41 | 230 | 0 | 255,524 |
| 2021 | 34 | 182 | 6 | 479,618 |
| 2022 | 34 | 243 | 0 | 483,224 |
| 2023 | 35 | 248 | 0 | 537,585 |
| 2024 | 40 | 222 | 1 | 473,629 |
| 2025 | 31 | 184 | 1 | 465,788 |
| 2026 | 15 | 194 | 2 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050586 · printed Nov 3, 2026
Cite this page
510(k) Report. “K050586: Leone Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050586
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026