510(k) · Cleared
ClearedTouareg NP Closefit Dental Implants System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Adin Dental Implants Systems, Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Oct 31, 2014 as substantially equivalent to K081751 (Adin Dental Implants System, Ltd., 2008) and 1 other predicate after a 268-day review. Its family tree reaches back 1 generation to 2008. 2 later devices descend from it.
- Decided
- Oct 31, 2014
- Review
- 268 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K080396 (2008). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK080396 Osseospeed NarrowAstra Tech AB · 2008
- This deviceK140293 Touareg NP Closefit Dental Implants SystemAdin Dental Implants Systems, Ltd. · 2014
- Descendant · cites it directly · 1 of its ownK153111 TOUAREG CloseFit™ UNP 2.75mmDAdin Dental Implants Systems, Ltd. · 2016
- Descendant · cites it directly · 0 of its ownK250178 Adin Customized AbutmentsAdin Dental Implant Systems, Ltd. · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K080396 | Osseospeed Narrow | Astra Tech AB | 2008 | — |
| 0 (this device) | K140293 | Touareg NP Closefit Dental Implants System | Adin Dental Implants Systems, Ltd. | 2014 | — |
| +1 | K153111 | TOUAREG CloseFit™ UNP 2.75mmD | Adin Dental Implants Systems, Ltd. | 2016 | — |
| +1 | K250178 | Adin Customized Abutments | Adin Dental Implant Systems, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K081751 | Adin Dental Implants SystemSummary page 5…ntal Implant traditional 510(k) Identification of Primary Legally Marketed Predicate Devices 1. ADIN Dental Implant Systems, Endosseous Dental Implant cleared under K081751, (product code DZE, Regulation No. 872.3640). 2. Asstra Tech AB OsseoSpeed™ Narrow Endosseous Dental Implant cleared un… | 2008 |
| * | K080396 | Osseospeed NarrowSummary page 5…Dental Implant cleared under K081751, (product code DZE, Regulation No. 872.3640). 2. Asstra Tech AB OsseoSpeed™ Narrow Endosseous Dental Implant cleared under K080396 (product code DZE, Regulation No. 872.3640). Device Description and function Adin Touareg NP CloseFit™ dental implants are… | 2008 |
What descends from it? (2)
2 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?
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
Intended use for Touareg NP CloseFit™ Dental Implant System: To replace missing masticatory functional units (teeth) in single or multiple unit applications within the mandible or maxilla. For single-stage or two-stage procedures. For immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations. When a one-stage surgical approach is applied, the implant maybe immediately loaded when good…
Read the full statement (117 words)
Intended use for Touareg NP CloseFit™ Dental Implant System:
To replace missing masticatory functional units (teeth) in single or multiple unit applications within the mandible or maxilla.
For single-stage or two-stage procedures.
For immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations. When a one-stage surgical approach is applied, the implant maybe immediately loaded when good primary stability is achieved and the functional load is appropriate.
The Touareg NP CloseFit™ Dental Implant shall only be used to replace maxillary lateral incisors and mandibular lateral and central incisors.
The Trans Mucosal Abutment (TMA) is indicated for multiple-unit, screw-retained restorations, and may be used in combination with an implant level framework design.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140293 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140293: Touareg NP Closefit Dental Implants System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140293
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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