510(k) · Cleared
ClearedImplus 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 Nov 28, 2007 as substantially equivalent to K011028 (Sulzer Dental, Inc., 2001) and 1 other predicate after a 426-day review. Its family tree reaches back 2 generations to 1993. 4 later devices descend from it.
- Decided
- Nov 28, 2007
- Review
- 426 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K925765 (1993). 3 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 1 generation backK021355 Endosseous ImplantBranemark Integration AB · 2002
- This deviceK062931 Implus Implant SystemLeader Italia S.R.L. · 2007
- Descendant · cites it directly · 2 of its ownK183024 Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda · 2020
- Descendant · 2 generations on · 0 of its ownK202832 Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda · 2021
- Descendant · cites it directly · 0 of its ownK192839 DSP Implant SystemD.S.P Industrial Eireli · 2021
- Descendant · cites it directly · 0 of its ownK120792 Tixos Implant SystemLeader Italia S.R.L. · 2012
Most influential descendants
Showing 4 of 4 · See all- K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda · 2020 · cites it directly2descendants
- K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda · 2021 · 2 generations on0descendants
- K192839DSP Implant SystemD.S.P Industrial Eireli · 2021 · cites it directly0descendants
- K120792Tixos Implant SystemLeader Italia S.R.L. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K925765 | Branemark System Standard 3.75MM Fixture | Nobelpharma USA, Inc. | 1993 | — |
| −1 | K021355 | Endosseous Implant | Branemark Integration AB | 2002 | — |
| 0 (this device) | K062931 | Implus Implant System | Leader Italia S.R.L. | 2007 | — |
| +1 | K183024 | Implacil Implant System | Implacil DE Bortoli Material Odontologico Ltda | 2020 | — |
| +2 | K202832 | Implacil Implant System | Implacil DE Bortoli Material Odontologico Ltda | 2021 | — |
| +1 | K192839 | DSP Implant System | D.S.P Industrial Eireli | 2021 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 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 |
|---|---|---|---|
| * | K011028 | Screw-Vent Dental Implant System | 2001 |
| * | K021355 | Endosseous ImplantSummary page 1…icate Devices * Sulzer Dental Screw-Vent Dental Implant System (KOlI 1028) vs IMPLUS * Branemark Integration Endosseous Implant (K021355) vs IMPLUS IV Product Description Leader Italia IMPLUS implants are available… | 2002 |
What descends from it? (4)
3 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 14 years and passes through 3 companies; a new generation was cleared every 8.9 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K183024 (Implacil DE Bortoli Material Odontologico Ltda, 2020) has gone furthest, with 2 descendants of its own.
- 15 other devices also cite its predicate K011028.
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?
IMPLUS implant fixtures are intended to be surgically placed in the bone of the mandibular and/or maxillary dental arches in order to provide support for fixed and/or removal prosthetics in order to restore original features and masticatory functions.
Implus implant fixtures are indicated for permanent use.
Implus implant fixtures are disposable and are for one-time use only. These fixtures are not to be re-cleaned or re-sterilized.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062931 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062931: Implus 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/K062931
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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