510(k) · Cleared
ClearedNeo Implant System
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 Mar 7, 2005 as substantially equivalent to K041492 (Astra Tech, Inc., 2004) and 3 other predicates after a 109-day review. Its family tree reaches back 2 generations to 1989. 167 later devices descend from it.
- Decided
- Mar 7, 2005
- Review
- 109 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K891615 (1989). 6 ancestors in all. 167 later devices descend from it, 6 citing it directly.
- Root · 2 generations backK891615 Surgical DrillsImplant Innovations International, Inc. · 1989
- 1 generation backK962014 3I Single Use, Disposable Drills,Taps,Burs, Etc.Implant Innovations, Inc. · 1996
- This deviceK043195 Neo Implant SystemNeoss, Ltd. · 2005
- Descendant · cites it directly · 105 of its ownK120954 Nobelprocera Peek AbutmentsNobel Biocare AB · 2013
- Descendant · 2 generations on · 101 of its ownK133731 Nobelactive Wide Platform (WP)Nobel Biocare AB · 2014
- Descendant · 3 generations on · 99 of its ownK142260 NobelActiveNobel Biocare AB · 2015
- Descendant · 4 generations on · 86 of its ownK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- Descendant · cites it directly · 74 of its ownK071838 Neoss Various Titanium AbutmentsNeoss, Ltd. · 2007
Showing 5 of 167 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 167 · See all- K120954Nobelprocera Peek AbutmentsNobel Biocare AB · 2013 · cites it directly105descendants
- K133731Nobelactive Wide Platform (WP)Nobel Biocare AB · 2014 · 2 generations on101descendants
- K142260NobelActiveNobel Biocare AB · 2015 · 3 generations on99descendants
- K170588DESS Dental Smart SolutionsTerrats Medical SL · 2017 · 4 generations on86descendants
- K071838Neoss Various Titanium AbutmentsNeoss, Ltd. · 2007 · cites it directly74descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K891615 | Surgical Drills | Implant Innovations International, Inc. | 1989 | — |
| −1 | K962014 | 3I Single Use, Disposable Drills,Taps,Burs, Etc. | Implant Innovations, Inc. | 1996 | — |
| 0 (this device) | K043195 | Neo Implant System | Neoss, Ltd. | 2005 | — |
| +1 | K120954 | Nobelprocera Peek Abutments | Nobel Biocare AB | 2013 | — |
| +2 | K133731 | Nobelactive Wide Platform (WP) | Nobel Biocare AB | 2014 | — |
| +3 | K142260 | NobelActive | Nobel Biocare AB | 2015 | — |
| +4 | K170588 | DESS Dental Smart Solutions | Terrats Medical SL | 2017 | — |
| +1 | K071838 | Neoss Various Titanium Abutments | Neoss, Ltd. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 5 | 0 |
| 2015 | 4 | 0 |
| 2016 | 6 | 0 |
| 2017 | 5 | 0 |
| 2018 | 6 | 0 |
| 2019 | 12 | 0 |
| 2020 | 10 | 0 |
| 2021 | 13 | 0 |
| 2022 | 17 | 0 |
| 2023 | 19 | 0 |
| 2024 | 22 | 0 |
| 2025 | 23 | 0 |
| 2026 | 16 | 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? (4)
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 |
|---|---|---|---|
| * | K041492 | Astra Tech Implants - Dental SystemSummary page 1…he following implant fixtures including temporary parts (cover screw and healing abutment); - Astra Tech Implants lDental System- Immediate function, nr K04 1492 and the following abutments: - Astra Tech Implants- Dental system, nr K93 1767 (Neo Titanium, Neo gold, ball, b… | 2004 |
| * | K931767 | Astra Tech Implants-Dental SystemSummary page 1…- Astra Tech Implants lDental System- Immediate function, nr K04 1492 and the following abutments: - Astra Tech Implants- Dental system, nr K93 1767 (Neo Titanium, Neo gold, ball, bar, abutment screw) - Astra Tech implant- Dental System Additional compo… | 1994 |
| * | K974738 | Astra Tech Implant Dental SystemSummary page 1…ts- Dental system, nr K93 1767 (Neo Titanium, Neo gold, ball, bar, abutment screw) - Astra Tech implant- Dental System Additional components, nr K974738. (Ti prepable abutments). Neoss Ltd also believes the bone cutting instruments are substantially equivalen… | 1998 |
| * | K962014 | 3I Single Use, Disposable Drills,Taps,Burs, Etc.Summary page 1…the bone cutting instruments are substantially equivalent to the loallowing implant fixtures; - 3i single use, disposable drills, taps, burs etc.- nr K962014 (non-sterile reusable components)… | 1996 |
What descends from it? (167)
See all 1676 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 16 years and passes through 3 companies; a new generation was cleared every 8.4 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K120954 (Nobel Biocare AB, 2013) has gone furthest, with 105 descendants of its own.
- 1 other device also cites its predicate K041492.
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 Neo Implants - Neo Implant System are for single-stage and two-stage surgical procedures and cement or screw retained restorations.
The Neo Implants - Neo Implant System are intended tor immediate placement and function 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043195 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043195: Neo Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043195
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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