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 May 9, 2016 as substantially equivalent to K140806 (Innobiosurg Co., Ltd., 2015) and 3 other predicates after a 171-day review. Its family tree reaches back 13 generations to 1990. 7 later devices descend from it.
- Decided
- May 9, 2016
- Review
- 171 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 13 generations to K894595 (1990). 100 ancestors in all, the oldest K894844 (1990). 7 later devices descend from it, 3 citing it directly.
- Root · 13 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 9 generations between
- 3 generations backK101096 HT Iii SA Fixture SystemHiossen, Inc. · 2010
- 2 generations backK121585 TS Implant SystemOsstem Implant Co., Ltd. · 2013
- 1 generation backK140507 Hiossen Prosthetic SystemOsstem Implant Co., Ltd. · 2014
- This deviceK153350 IBS Implant SystemInnobiosurg Co., Ltd. · 2016
- Descendant · cites it directly · 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
- Descendant · 2 generations on · 1 of its ownK200753 IBS Implant System IIInnobiosurg Co., Ltd. · 2020
Show all 13 generations
- Root · 13 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 12 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 11 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 10 generations backK011879 3A Dental Implant SystemOsseco Biosource, Ltd. · 2002
- 9 generations backK051576 Avana Dental Implant SystemOsstem Co., Ltd. · 2005
- 8 generations backK062051 SS SystemOsstem Implant Co., Ltd. · 2006
- 7 generations backK063861 GS SystemOsstem Implant Co., Ltd. · 2007
- 6 generations backK080744 HG II Fixture SystemOsstem Implant Co., Ltd. · 2008
- 5 generations backK082213 GS Iii Fixture SystemOsstem Implant Co., Ltd. · 2008
- 4 generations backK093352 HG Iii Fixture SystemHiossen, Inc. · 2009
- 3 generations backK101096 HT Iii SA Fixture SystemHiossen, Inc. · 2010
- 2 generations backK121585 TS Implant SystemOsstem Implant Co., Ltd. · 2013
- 1 generation backK140507 Hiossen Prosthetic SystemOsstem Implant Co., Ltd. · 2014
- This deviceK153350 IBS Implant SystemInnobiosurg Co., Ltd. · 2016
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K162099IBS Implant System IIInnobiosurg Co., Ltd. · 2017 · cites it directly5descendants
- 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
- K200753IBS Implant System IIInnobiosurg Co., Ltd. · 2020 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −12 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −11 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −10 | K011879 | 3A Dental Implant System | Osseco Biosource, Ltd. | 2002 | — |
| −9 | K051576 | Avana Dental Implant System | Osstem Co., Ltd. | 2005 | — |
| −8 | K062051 | SS System | Osstem Implant Co., Ltd. | 2006 | — |
| −7 | K063861 | GS System | Osstem Implant Co., Ltd. | 2007 | — |
| −6 | K080744 | HG II Fixture System | Osstem Implant Co., Ltd. | 2008 | — |
| −5 | K082213 | GS Iii Fixture System | Osstem Implant Co., Ltd. | 2008 | — |
| −4 | K093352 | HG Iii Fixture System | Hiossen, Inc. | 2009 | — |
| −3 | K101096 | HT Iii SA Fixture System | Hiossen, Inc. | 2010 | — |
| −2 | K121585 | TS Implant System | Osstem Implant Co., Ltd. | 2013 | — |
| −1 | K140507 | Hiossen Prosthetic System | Osstem Implant Co., Ltd. | 2014 | — |
| 0 (this device) | K153350 | IBS Implant System | Innobiosurg Co., Ltd. | 2016 | — |
| +1 | 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 | — |
| +2 | K200753 | IBS Implant System II | Innobiosurg Co., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 6 | 0 |
| 1997 | 4 | 0 |
| 1998 | 2 | 0 |
| 1999 | 6 | 0 |
| 2000 | 2 | 0 |
| 2001 | 7 | 0 |
| 2002 | 9 | 0 |
| 2003 | 4 | 0 |
| 2004 | 5 | 0 |
| 2005 | 3 | 0 |
| 2006 | 6 | 0 |
| 2007 | 6 | 0 |
| 2008 | 7 | 0 |
| 2009 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K140806 | Ibs Implant SystemSummary page 6…omparison of the technological characteristics of the subject device and predicate devices is shown in the Table of Substantial Equivalence below. 1) Fixture • K140806, IBS Implant System by InnoBioSurg Co., Ltd. Subject Device P… | 2015 |
| * | K140507 | Hiossen Prosthetic SystemSummary page 7…, self tapping Technique Gamma Yes Yes Sterilization 2) Abutments • K140507, Hiossen Prosthetic System by Osstem Implant Co., Ltd. • K123755, Multi Angled Abutment by Osstem Implant Co., Ltd. •… | 2014 |
| * | K123755 | Multi Angled AbutmentSummary page 7…Yes Yes Sterilization 2) Abutments • K140507, Hiossen Prosthetic System by Osstem Implant Co., Ltd. • K123755, Multi Angled Abutment by Osstem Implant Co., Ltd. • K111120, CSM Submerged-R Implant System by CSM Implant… | 2013 |
| * | K111120 | CSM Submerged-R Implant SystemSummary page 7…tion 2) Abutments • K140507, Hiossen Prosthetic System by Osstem Implant Co., Ltd. • K123755, Multi Angled Abutment by Osstem Implant Co., Ltd. • K111120, CSM Submerged-R Implant System by CSM Implant Predicate d… | 2011 |
What descends from it? (7)
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?
- The line of descent spans 26 years and passes through 8 companies; a new generation was cleared every 1.2 years on median.
- 9 of the 100 ancestors have a recall of any class.
- Of its descendants, K162099 (Innobiosurg Co., Ltd., 2017) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K140806.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 as stated in the FDA summary.
https://510kreport.com/device/K153350 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153350: IBS 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/K153350
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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