510(k) · Cleared
ClearedS-Mini Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neobiotech Co., Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Feb 3, 2012 as substantially equivalent to K080594 (Osstem Implant Co., Ltd., 2008) and 3 other predicates after a 155-day review. Its family tree reaches back 11 generations to 1996. 5 later devices descend from it.
- Decided
- Feb 3, 2012
- Review
- 155 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 11 generations to K960026 (1996). 26 ancestors in all. 5 later devices descend from it, 4 citing it directly.
- Root · 11 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 7 generations between
- 3 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 2 generations backK072959 MS System (Denture)Osstem Implant Co., Ltd. · 2008
- 1 generation backK080594 MS System (Narrow Ridge)Osstem Implant Co., Ltd. · 2008
- This deviceK112540 S-Mini Implant SystemNeobiotech Co., Ltd. · 2012
- Descendant · cites it directly · 1 of its ownK133050 One Plus Implant SystemOsseofuse, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK241127 INNO SLA Mini Plus® Implant SystemCowellmedi Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK181178 S-mini active FixtureNeobiotech Co., Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK170394 Kisses MiniAchimhai Medical Corporation · 2017
- Descendant · 2 generations on · 0 of its ownK151970 KJ Mini Implant SystemKj Meditech Co., Ltd. · 2016
Show all 11 generations
- Root · 11 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 10 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 9 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 8 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 7 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 6 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 5 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 4 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 3 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 2 generations backK072959 MS System (Denture)Osstem Implant Co., Ltd. · 2008
- 1 generation backK080594 MS System (Narrow Ridge)Osstem Implant Co., Ltd. · 2008
- This deviceK112540 S-Mini Implant SystemNeobiotech Co., Ltd. · 2012
Most influential descendants
Showing 5 of 5 · See all- K133050One Plus Implant SystemOsseofuse, Inc. · 2014 · cites it directly1descendant
- K241127INNO SLA Mini Plus® Implant SystemCowellmedi Co., Ltd. · 2024 · cites it directly0descendants
- K181178S-mini active FixtureNeobiotech Co., Ltd. · 2018 · cites it directly0descendants
- K170394Kisses MiniAchimhai Medical Corporation · 2017 · cites it directly0descendants
- K151970KJ Mini Implant SystemKj Meditech Co., Ltd. · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −10 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −9 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −8 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −7 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −6 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −5 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −4 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −3 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −2 | K072959 | MS System (Denture) | Osstem Implant Co., Ltd. | 2008 | — |
| −1 | K080594 | MS System (Narrow Ridge) | Osstem Implant Co., Ltd. | 2008 | — |
| 0 (this device) | K112540 | S-Mini Implant System | Neobiotech Co., Ltd. | 2012 | — |
| +1 | K133050 | One Plus Implant System | Osseofuse, Inc. | 2014 | — |
| +1 | K241127 | INNO SLA Mini Plus® Implant System | Cowellmedi Co., Ltd. | 2024 | — |
| +1 | K181178 | S-mini active Fixture | Neobiotech Co., Ltd. | 2018 | — |
| +1 | K170394 | Kisses Mini | Achimhai Medical Corporation | 2017 | — |
| +2 | K151970 | KJ Mini Implant System | Kj Meditech Co., Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2024 | 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? (4)
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 |
|---|---|---|---|
| * | K080594 | MS System (Narrow Ridge)Summary page 2…compressive load, and retention force testing, were performed successfully. Predicate devices * Cement Type MS Implant(Narrow Reidge) by OSSTEM Implant., Ltd, K080594 Intermezzo TmImplant System by Megagen Co., ltd. K05 1018 * Ball Type MS Implant (Denture) by OSSTEM Implant., Ltd., K072… | 2008 |
| * | K051018 | Intermezzo Implant SystemsSummary page 2…ormed successfully. Predicate devices * Cement Type MS Implant(Narrow Reidge) by OSSTEM Implant., Ltd, K080594 Intermezzo TmImplant System by Megagen Co., ltd. K05 1018 * Ball Type MS Implant (Denture) by OSSTEM Implant., Ltd., K072959 DIO Protein Implant System by DIO Department, DSI, Inc… | 2005 |
| * | K072959 | MS System (Denture)Summary page 2…row Reidge) by OSSTEM Implant., Ltd, K080594 Intermezzo TmImplant System by Megagen Co., ltd. K05 1018 * Ball Type MS Implant (Denture) by OSSTEM Implant., Ltd., K072959 DIO Protein Implant System by DIO Department, DSI, Inc., K080126 Comparison Chart C… | 2008 |
| * | K080126 | Dio Protem Implant SystemSummary page 2…System by Megagen Co., ltd. K05 1018 * Ball Type MS Implant (Denture) by OSSTEM Implant., Ltd., K072959 DIO Protein Implant System by DIO Department, DSI, Inc., K080126 Comparison Chart Cement type S-MiNi Implant… | 2008 |
What descends from it? (5)
4 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?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 8 months on median.
- 4 of the 26 ancestors have a recall of any class.
- Of its descendants, K133050 (Osseofuse, Inc., 2014) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K080594.
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?
The S-MiNi Implant System is divided into two types:
- Cement Type
The Cement type is indicated for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors to serve as temporary support prosthetic devices during the healing phase of permanent endosseous dental implant, such as artificial teeth, in order to restore chewing function in partially edentulous patients.
- Ball Type
The Ball type is designed for use in dental implant surgery. Ball type is intended for use in partially or fully edentulous mandibles and maxillae, in support of overdentures. Ball type implants are for temporary use, only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112540 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112540: S-Mini 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/K112540
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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