510(k) · Cleared
ClearedTouareg Closefit Dental Impant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Adin Dental Implants System, Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on May 24, 2012 as substantially equivalent to K081751 (Adin Dental Implants System, Ltd., 2008) after a 261-day review. Its family tree reaches back 1 generation to 2008. 2 later devices descend from it.
- Decided
- May 24, 2012
- Review
- 261 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K081751 (2008). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK081751 Adin Dental Implants SystemAdin Dental Implants System, Ltd. · 2008
- This deviceK112585 Touareg Closefit Dental Impant SystemAdin Dental Implants System, Ltd. · 2012
- Descendant · cites it directly · 1 of its ownK223714 UniFit Dental Implant SystemAdin Dental Implant Systems, Ltd. · 2023
- 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 | K081751 | Adin Dental Implants System | Adin Dental Implants System, Ltd. | 2008 | — |
| 0 (this device) | K112585 | Touareg Closefit Dental Impant System | Adin Dental Implants System, Ltd. | 2012 | — |
| +1 | K223714 | UniFit Dental Implant System | Adin Dental Implant Systems, Ltd. | 2023 | — |
| +1 | K250178 | Adin Customized Abutments | Adin Dental Implant Systems, Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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? (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 |
|---|---|---|---|
| * | K081751 | Adin Dental Implants SystemSummary page 1…Dental Devices Regulatory Class: 11 Identification of Legzally Marketed Predicate Devices Adin Dental Implants System - K081751 Vol_006-1 Device Description… | 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. 2012, 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 CloseFitTM Dental Implants are intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous or partially edentulous patients.
Touareg CloseFitTM Dental Implants may be immediately loaded when good primary stability is achieved and with appropriate occlusal loading
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112585 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112585: Touareg Closefit Dental Impant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112585
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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