510(k) · Cleared
ClearedNeoss Implant System 03.25
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neoss, Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on May 22, 2009 as substantially equivalent to K043195 (Neoss, Ltd., 2005) and 2 other predicates after an 88-day review. Its family tree reaches back 4 generations to 1989. 3 later devices descend from it.
- Decided
- May 22, 2009
- Review
- 88 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K891615 (1989). 12 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK891615 Surgical DrillsImplant Innovations International, Inc. · 1989
- 3 generations backK962014 3I Single Use, Disposable Drills,Taps,Burs, Etc.Implant Innovations, Inc. · 1996
- 2 generations backK043195 Neo Implant SystemNeoss, Ltd. · 2005
- 1 generation backK071838 Neoss Various Titanium AbutmentsNeoss, Ltd. · 2007
- This deviceK090452 Neoss Implant System 03.25Neoss, Ltd. · 2009
- 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 · 2 generations on · 0 of its ownK192839 DSP Implant SystemD.S.P Industrial Eireli · 2021
Most influential descendants
Showing 3 of 3 · 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 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K891615 | Surgical Drills | Implant Innovations International, Inc. | 1989 | — |
| −3 | K962014 | 3I Single Use, Disposable Drills,Taps,Burs, Etc. | Implant Innovations, Inc. | 1996 | — |
| −2 | K043195 | Neo Implant System | Neoss, Ltd. | 2005 | — |
| −1 | K071838 | Neoss Various Titanium Abutments | Neoss, Ltd. | 2007 | — |
| 0 (this device) | K090452 | Neoss Implant System 03.25 | Neoss, Ltd. | 2009 | — |
| +1 | K183024 | Implacil Implant System | Implacil DE Bortoli Material Odontologico Ltda | 2020 | — |
| +2 | K202832 | Implacil Implant System | Implacil DE Bortoli Material Odontologico Ltda | 2021 | — |
| +2 | K192839 | DSP Implant System | D.S.P Industrial Eireli | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K043195 | Neo Implant SystemSummary page 2…mplant, Endosseous, Root Form; 872.3630 Abutment, implant, dental, endosseous Predicate Device: Neoss Bimodal Implant K043195, Neoss ProActive Implant K083561 and Neoss Abutment System K071838. Device Descript… | 2005 |
| * | K083561 | Neoss Proactive ImplantSummary page 2…implant, dental, endosseous Predicate Device: Neoss Bimodal Implant K043195, Neoss ProActive Implant K083561 and Neoss Abutment System K071838. Device Description: The Neoss Implant System 03,25 assortment consists of a numb… | 2009 |
| * | K071838 | Neoss Various Titanium AbutmentsSummary page 2…us Predicate Device: Neoss Bimodal Implant K043195, Neoss ProActive Implant K083561 and Neoss Abutment System K071838. Device Description: The Neoss Implant System 03,25 assortment consists of a number of implants with a diamet… | 2007 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K183024 | Implacil Implant System | 2020 | 2 |
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 20 years and passes through 3 companies; a new generation was cleared every 7.5 years on median.
- 2 of the 12 ancestors have 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.
- 5 other devices also cite its predicate K043195.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Neoss Implant System 03,25 is for single-stage and two-stage surgical procedures and cement or screw retained restorations.
The Neoss Implant System 03,25 are intended for immediate loading on single tooth and /or multiple tooth applications recognizing sufficient bone stability and appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be splinted with a bar.
The Neoss Implant 03,25 abutments are designed to be connected to the Neoss implants and intended for use as an aid in prosthetic rehabilitation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090452 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090452: Neoss Implant System 03.25.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090452
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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