510(k) · Cleared
ClearedIbs Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innobiosurg Co., Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Mar 23, 2015 after a 356-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 8 later devices descend from it.
- Decided
- Mar 23, 2015
- Review
- 356 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 3 citing it directly.
- This deviceK140806 Ibs Implant SystemInnobiosurg Co., Ltd. · 2015
- Descendant · cites it directly · 7 of its ownK153350 IBS Implant SystemInnobiosurg Co., Ltd. · 2016
- Descendant · 2 generations on · 5 of its ownK162099 IBS Implant System IIInnobiosurg Co., Ltd. · 2017
- Descendant · cites it directly · 3 of its ownK173120 CCM Abutment SystemInnobiosurg Co., Ltd. · 2018
- Descendant · 2 generations on · 2 of its ownK202418 Magic UCLA Abutment SystemInnobiosurg Co., Ltd. · 2020
- Descendant · 2 generations on · 1 of its ownK212517 Magicore SystemInnobiosurg Co., Ltd. · 2021
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K153350IBS Implant SystemInnobiosurg Co., Ltd. · 2016 · cites it directly7descendants
- K162099IBS Implant System IIInnobiosurg Co., Ltd. · 2017 · 2 generations on5descendants
- K173120CCM Abutment SystemInnobiosurg Co., Ltd. · 2018 · cites it directly3descendants
- K202418Magic UCLA Abutment SystemInnobiosurg Co., Ltd. · 2020 · 2 generations on2descendants
- K212517Magicore SystemInnobiosurg Co., Ltd. · 2021 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K140806 | Ibs Implant System | Innobiosurg Co., Ltd. | 2015 | — |
| +1 | K153350 | IBS Implant System | Innobiosurg Co., Ltd. | 2016 | — |
| +2 | K162099 | IBS Implant System II | Innobiosurg Co., Ltd. | 2017 | — |
| +1 | K173120 | CCM Abutment System | Innobiosurg Co., Ltd. | 2018 | — |
| +2 | K202418 | Magic UCLA Abutment System | Innobiosurg Co., Ltd. | 2020 | — |
| +2 | K212517 | Magicore System | Innobiosurg Co., Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (8)
3 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?
- Of its descendants, K153350 (Innobiosurg Co., Ltd., 2016) has gone furthest, with 7 descendants of its own.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 IBS implant System is intended to replace missing teeth to restore chewing function.
The IBS implant can be placed in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations, and terminal or immediate abutment support for fixed bridgework. This system is for one or two stage surgical procedures. This system is intended for delayed loading.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K140806 · printed Nov 4, 2026
Cite this page
510(k) Report. “K140806: Ibs 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/K140806
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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