510(k) · Cleared
ClearedTOUAREG CloseFit™ UNP 2.75mmD
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 May 6, 2016 as substantially equivalent to K140293 (Adin Dental Implants Systems, Ltd., 2014) after a 191-day review. Its family tree reaches back 2 generations to 2008. 1 later device descends from it.
- Decided
- May 6, 2016
- Review
- 191 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K080396 (2008). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK080396 Osseospeed NarrowAstra Tech AB · 2008
- 1 generation backK140293 Touareg NP Closefit Dental Implants SystemAdin Dental Implants Systems, Ltd. · 2014
- This deviceK153111 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 1 of 1 · See all- K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K080396 | Osseospeed Narrow | Astra Tech AB | 2008 | — |
| −1 | K140293 | Touareg NP Closefit Dental Implants System | Adin Dental Implants Systems, Ltd. | 2014 | — |
| 0 (this device) | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K140293 | Touareg NP Closefit Dental Implants SystemSummary page 5…5 Predicate Devices: Primary Predicate: Adin Dental Implant Systems Ltd. dental implants Touareg CloseFit™ NP, cleared under 510(k) K140293. Reference Predicates: Anthogyr SAS’ Axiom 2.8 implant cleared under 510(k) K141450 and Adin Dental Implant System… | 2014 |
| † | K141450 | AXIOM 2.8 | 2014 |
| † | K112585 | Touareg Closefit Dental Impant System | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250178 | Adin Customized Abutments | 2025 | 0 |
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 8 years and passes through 2 companies; a new generation was cleared every 6.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K250178 (Adin Dental Implant Systems, Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K140293.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
TOUAREG CloseFit™ UNP 2.75mmD implants are indicated 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 an 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 CloseFit™ UNP 2.75mmD Dental Implant shall only be used to replace maxillary lateral incisors and mandibular lateral and central incisors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153111 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153111: TOUAREG CloseFit™ UNP 2.75mmD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153111
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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