510(k) · Cleared
ClearedINOSS System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inosys, Inc. · DZE Implant, Endosseous, Root-Form
Cleared on Jun 17, 2026 as substantially equivalent to K170608 (Dio Corporation, 2018) after a 166-day review. Its family tree reaches back 4 generations to 2004.
- Decided
- Jun 17, 2026
- Review
- 166 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K041368 (2004). No later device cites it as a predicate yet.
- Root · 4 generations backK041368 Dentium CO., LTD. ImplantiumDentium Co., Ltd. · 2004 · Recalled
- 3 generations backK060501 Implantium IIDentium Co., Ltd. · 2006
- 2 generations backK122519 Dio UF Hsa Internal Sub-Merged Implant SystemDio Corporation · 2013
- 1 generation backK170608 UF (II) Implant SystemDio Corporation · 2018
- This deviceK260006 INOSS SystemInosys, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K041368 | Dentium CO., LTD. Implantium | Dentium Co., Ltd. | 2004 | 1 |
| −3 | K060501 | Implantium II | Dentium Co., Ltd. | 2006 | — |
| −2 | K122519 | Dio UF Hsa Internal Sub-Merged Implant System | Dio Corporation | 2013 | — |
| −1 | K170608 | UF (II) Implant System | Dio Corporation | 2018 | — |
| 0 (this device) | K260006 | INOSS System | Inosys, Inc. | 2026 | — |
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 |
|---|---|---|---|
| * | K170608 | UF (II) Implant SystemSummary page 5…tion : II Primary Product Code : DZE Secondary Product Code : NHA Regulation Number : 872.3640 Date Prepared : June 15, 2026 Predicate Device • Predicate device K170608, DIO Corporation, UF(II) Implant System • Reference devices K182194, DIO Corporation, UV Active Implant System K212533, In… | 2018 |
| † | K182194 | UV Active Implant System | 2018 |
| † | K212533 | BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants | 2022 |
| † | K163194 | Neodent Implant System - GM Line | 2017 |
| † | K210826 | Healing Abutment, Cover Screw | 2022 |
| † | K182081 | JDentalCare Implant System JDIcon | 2020 |
| † | K222636 | ET Abutment System | 2023 |
| † | K172100 | URIS OMNI System | 2018 |
| † | K161689 | OSSTEM Implant System - Abutment | 2017 |
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 22 years and passes through 3 companies; a new generation was cleared every 6.9 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 1 other device also cites its predicate K170608.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
INOSS System is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single-units' prosthetic attachment to restore a patient's chewing function. INOSS System can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading when good primary stability is achieved with appropriate occlusal loading.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260006 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260006: INOSS System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260006
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026