510(k) · Cleared
ClearedINNO SLA Mini Plus® Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cowellmedi Co., Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Dec 27, 2024 as substantially equivalent to K112540 (Neobiotech Co., Ltd., 2012) and 1 other predicate after a 248-day review. Its family tree reaches back 12 generations to 1996.
- Decided
- Dec 27, 2024
- Review
- 248 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K960026 (1996). 28 ancestors in all. No later device cites it as a predicate yet.
- Root · 12 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 8 generations between
- 3 generations backK072959 MS System (Denture)Osstem Implant Co., Ltd. · 2008
- 2 generations backK080594 MS System (Narrow Ridge)Osstem Implant Co., Ltd. · 2008
- 1 generation backK083067 MS SystemOsstem Implant Co., Ltd. · 2009
- This deviceK241127 INNO SLA Mini Plus® Implant SystemCowellmedi Co., Ltd. · 2024
Show all 12 generations
- Root · 12 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 11 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 10 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 9 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 8 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 7 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 6 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 5 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 4 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 3 generations backK072959 MS System (Denture)Osstem Implant Co., Ltd. · 2008
- 2 generations backK080594 MS System (Narrow Ridge)Osstem Implant Co., Ltd. · 2008
- 1 generation backK083067 MS SystemOsstem Implant Co., Ltd. · 2009
- This deviceK241127 INNO SLA Mini Plus® Implant SystemCowellmedi Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −11 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −10 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −9 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −8 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −7 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −6 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −5 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −4 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −3 | K072959 | MS System (Denture) | Osstem Implant Co., Ltd. | 2008 | — |
| −2 | K080594 | MS System (Narrow Ridge) | Osstem Implant Co., Ltd. | 2008 | — |
| −1 | K083067 | MS System | Osstem Implant Co., Ltd. | 2009 | — |
| 0 (this device) | K241127 | INNO SLA Mini Plus® Implant System | Cowellmedi Co., Ltd. | 2024 | — |
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 |
| 2012 | 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? (2)
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 |
|---|---|---|---|
| * | K112540 | S-Mini Implant SystemSummary page 5…Implant, Endosseous, Root-Form Classification Product Code: DZE, NHA 4. Predicate Devices: • Primary Predicate: S-Mini Implant System (K112540) by Neobiotech Co., Ltd. • Reference Device: AnyOne Onestage Implant System (K210161) by MegaGen Implant Co., Ltd.… | 2012 |
| * | K083067 | MS SystemSummary page 5…em (K201323) by Cowellmedi Co., Ltd. • Reference Device: INNO SLA Submerged Implant System (K132242) by Cowellmedi Co., Ltd. • Reference Device: MS System (K083067) by Osstem Implant Co., Ltd. Page 1 of 9 5. Device Description:… | 2009 |
| † | K210161 | AnyOne Onestage Implant System | 2021 |
| † | K200827 | LOCATOR R-Tx | 2020 |
| † | K201323 | INNO SLA Submerged Implant System | 2022 |
| † | K132242 | Inno Sla Submerged Implant System | 2013 |
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?
- The line of descent spans 28 years and passes through 3 companies; a new generation was cleared every 8 months on median.
- 4 of the 28 ancestors have a recall of any class.
- 3 other devices also cite its predicate K112540.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 INNO SLA Mini Plus® Implant System is divided into two types: - Cemented 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 stage of permanent endosseous dental implant, such as artificial teeth, in order to restore masticating function in partially edentulous patients. - Ball Type The Ball…
Read the full statement (141 words)
The INNO SLA Mini Plus® Implant System is divided into two types:
- Cemented 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 stage of permanent endosseous dental implant, such as artificial teeth, in order to restore masticating function in partially edentulous patients.
- Ball Type
The Ball type is designed for use in dental implant surgery. The Ball type is intended for use in partially or fully edentulous mandibles and maxillae, in support of overdentures. The use of the Ball type implants is not to exceed one hundred and eighty (180) days.
The Cemented Type and Ball Type implant bodies are indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241127 · printed Nov 4, 2026
Cite this page
510(k) Report. “K241127: INNO SLA Mini Plus® Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K241127
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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