510(k) · Cleared
ClearedLeone Monoimplant for O-Ring Overdenture
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 Apr 19, 2007 as substantially equivalent to K031106 (Imtec Corp., 2003) and 1 other predicate after a 58-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Apr 19, 2007
- Review
- 58 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K935544 (1995). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK935544 3I Standard Threaded/Self-Tapping Threaded Implants ModificationImplant Innovations International, Inc. · 1995
- 3 generations backK013570 Osseotite Dental ImplantsImplant Innovations, Inc. · 2001
- 2 generations backK031055 Iti Dental Implant SystemStraumann USA · 2003
- 1 generation backK050586 Leone Implant SystemLeone S.P.A. · 2006
- This deviceK070483 Leone Monoimplant for O-Ring OverdentureLeone S.P.A. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K935544 | 3I Standard Threaded/Self-Tapping Threaded Implants Modification | Implant Innovations International, Inc. | 1995 | — |
| −3 | K013570 | Osseotite Dental Implants | Implant Innovations, Inc. | 2001 | — |
| −2 | K031055 | Iti Dental Implant System | Straumann USA | 2003 | — |
| −1 | K050586 | Leone Implant System | Leone S.P.A. | 2006 | — |
| 0 (this device) | 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 |
| 2003 | 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 |
|---|---|---|---|
| * | K031106 | Imtec Sendax Mdi and Mdi Plus Endosseous Implant, Models OB-XX, SH-XX, Mob-22, MSH-XXSummary page 1…Endosseous Dental Implant The legally marketed device to which we are claiming equivalence [21 CFR 807.92(a)(3)]: Imtec Corporation, IMTEC Sendax MDI and MDI Plus (K031106) Leone SpA, Leone Implant System (K050586) Description of the device: The Leone Monoimplant for 0-ring overdenture i… | 2003 |
| * | K050586 | Leone Implant SystemSummary page 1…evice to which we are claiming equivalence [21 CFR 807.92(a)(3)]: Imtec Corporation, IMTEC Sendax MDI and MDI Plus (K031106) Leone SpA, Leone Implant System (K050586) Description of the device: The Leone Monoimplant for 0-ring overdenture is a one-piece endosseous dental implant w… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
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 12 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 8 ancestors has a recall of any class.
- 22 other devices also cite its predicate K031106.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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 Monoimplants for O-ring overdenture are indicated as therapy for the stabilization of removable prosthesis on lower arch. The Leone Monoimplants for O-ring overdenture are designed to be surgically inserted in the bone structure of the mouth, exclusively in the mandible at the level of the area between the two foramina, as an anchorage system for total removable prosthesis. To properly support a removable prosthesis, four monoimplants have to be inserted.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070483 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070483: Leone Monoimplant for O-Ring Overdenture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070483
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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