510(k) · Cleared
ClearedTixos Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Leader Italia S.R.L. · DZE Implant, Endosseous, Root-Form
Cleared on Sep 5, 2012 as substantially equivalent to K062931 (Leader Italia S.R.L., 2007) after a 174-day review. Its family tree reaches back 3 generations to 1993.
- Decided
- Sep 5, 2012
- Review
- 174 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K925765 (1993). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 2 generations backK021355 Endosseous ImplantBranemark Integration AB · 2002
- 1 generation backK062931 Implus Implant SystemLeader Italia S.R.L. · 2007
- This deviceK120792 Tixos Implant SystemLeader Italia S.R.L. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K925765 | Branemark System Standard 3.75MM Fixture | Nobelpharma USA, Inc. | 1993 | — |
| −2 | K021355 | Endosseous Implant | Branemark Integration AB | 2002 | — |
| −1 | K062931 | Implus Implant System | Leader Italia S.R.L. | 2007 | — |
| 0 (this device) | K120792 | Tixos Implant System | Leader Italia S.R.L. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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? (1)
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 |
|---|---|---|---|
| * | K062931 | Implus Implant SystemSummary page 6…alia's TiXos Implant System, as designed and manufactured, is therefore determined to be substantially equivalent to their IMPLUS Implant System previously cleared under K062931. Page 6 of 6 DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Servic… | 2007 |
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 19 years and passes through 3 companies; a new generation was cleared every 5.2 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 2 other devices also cite its predicate K062931.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
TiXos dental implants are permanent devices for single use only that are intended to be surgically placed in the bone of the mandibular and/or maxillary dental arches of the patient in order to restore their original dental function and aesthetic features by providing support for fixed and/or removal prosthesis. TiXos dental implants can support single tooth, multiple tooth, or total prosthesis restorations and are compatible with the following dental abutments manufactured by Leader Italia that were previously cleared under K062931.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120792 · printed Nov 5, 2026
Cite this page
510(k) Report. “K120792: Tixos Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120792
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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