510(k) · Cleared
ClearedAdin Short Implants
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 Jul 8, 2022 as substantially equivalent to K081751 (Adin Dental Implants System, Ltd., 2008) after a 310-day review. Its family tree reaches back 1 generation to 2008.
- Decided
- Jul 8, 2022
- Review
- 310 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K081751 (2008). No later device cites it as a predicate yet.
- Root · 1 generation backK081751 Adin Dental Implants SystemAdin Dental Implants System, Ltd. · 2008
- This deviceK212775 Adin Short ImplantsAdin Dental Implants Systems, Ltd. · 2022
View 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) | K212775 | Adin Short Implants | Adin Dental Implants Systems, Ltd. | 2022 | — |
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 4…e substantially equivalent to the following Predicate Devices: 3.1 Primary predicate device: Adin's Dental Implants System, cleared under 510(k) number K081751 on December 19, 2008. 3.2 Reference device: Adin's Touareg CloseFitTM Dental Implant System, cleared under 510(… | 2008 |
| † | K112585 | Touareg Closefit Dental Impant System | 2012 |
| † | K103089 | Seven Implants; Biocom Implants; Lance Implants | 2011 |
| † | K102034 | Blue Sky Bio Dental Implant System | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 4 other devices also cite its predicate K081751.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
Adin Dental Implants are intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in fully or partially edentulous patients in order to restore a patient's chewing function.
Adin Dental Implants may be immediately loaded when good primary stability is achieved and with appropriate occlusal loading. Adin short implants are to be used only with straight abutments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212775 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212775: Adin Short Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212775
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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