510(k) · Cleared
ClearedUniFit Dental Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Adin Dental Implant Systems, Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Dec 29, 2023 as substantially equivalent to K112585 (Adin Dental Implants System, Ltd., 2012) after a 382-day review. Its family tree reaches back 2 generations to 2008. 1 later device descends from it.
- Decided
- Dec 29, 2023
- Review
- 382 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K081751 (2008). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK081751 Adin Dental Implants SystemAdin Dental Implants System, Ltd. · 2008
- 1 generation backK112585 Touareg Closefit Dental Impant SystemAdin Dental Implants System, Ltd. · 2012
- This deviceK223714 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 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 | K081751 | Adin Dental Implants System | Adin Dental Implants System, Ltd. | 2008 | — |
| −1 | K112585 | Touareg Closefit Dental Impant System | Adin Dental Implants System, Ltd. | 2012 | — |
| 0 (this device) | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K112585 | Touareg Closefit Dental Impant SystemSummary page 6…owing Predicate and Reference Devices: 3.1 Primary predicate device: Adin's Touareg™ CloseFit Dental Implant System, cleared under 510(k) number K112585 on May 24, 2012. 3.2 Reference device (for Ti Blank only): Imagine Milling Technologies, LLC’s MIST IC abutment… | 2012 |
| † | K182246 | Mist IC | 2019 |
| † | K081751 | Adin Dental Implants System | 2008 |
| † | K172505 | MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical… | 2017 |
| † | K103089 | Seven Implants; Biocom Implants; Lance Implants | 2011 |
| † | K173961 | Straumann BLX Implant System | 2018 |
| † | K140293 | Touareg NP Closefit Dental Implants System | 2014 |
| † | K173326 | MIS CONNECT Conical Connection Abutment | 2018 |
| † | K210903 | IS Multi Unit Abutment System | 2021 |
| † | K200817 | URIS OMNI Narrow System & Prosthetic | 2020 |
| † | K212628 | DESS Dental Smart Solutions | 2022 |
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 15 years and passes through 2 companies; a new generation was cleared every 11.6 years on median.
- None of the 2 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 K112585.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
UniFit Dental Implant System is intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges or overdentures in partially or completely edentulous patients in order to restore masticatory function. UniFit Dental Implants may be immediately loaded when good primary stability is achieved and with appropriate occlusal loading.
UniFit short implants (6 mm L) are intended to be used only with straight abutments.
All digitally designed custom abutments for use with Ti Base abutments or Pre-milled Blank abutments are to be sent to an Adin Dental validated milling center for manufacture.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223714 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223714: UniFit Dental 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/K223714
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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