510(k) · Cleared
ClearedZENEX Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Izenimplant Co., Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Apr 13, 2022 as substantially equivalent to K161604 (Osstem Implant Co., Ltd., 2016) and 2 other predicates after a 366-day review. Its family tree reaches back 15 generations to 1990. 8 later devices descend from it.
- Decided
- Apr 13, 2022
- Review
- 366 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 15 generations to K894595 (1990). 240 ancestors in all, the oldest K781060 (1978). 8 later devices descend from it, 6 citing it directly.
- Root · 15 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 11 generations between
- 3 generations backK132067 Multi Angled Abutment SystemHiossen, Inc. · 2013
- 2 generations backK160670 ET US SS Prosthetic systemOsstem Implant Co., Ltd. · 2017
- 1 generation backK182091 Osstem Abutment SystemOsstem Implant Co., Ltd. · 2019
- This deviceK211090 ZENEX Implant SystemIzenimplant Co., Ltd. · 2022
- Descendant · cites it directly · 1 of its ownK252585 ZENEX Implant System_R-SystemIzenimplant Co., Ltd. · 2026
- Descendant · cites it directly · 1 of its ownK231426 8plant Implant SystemHoowon Edi Co., Ltd. · 2024
- Descendant · cites it directly · 1 of its ownK231753 Oneday Implant AbutmentOneday Biotech Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK253334 ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK251605 DIMPLO Implant SystemDIMPLO, Ltd. · 2025
Show all 15 generations
- Root · 15 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 14 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 13 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 12 generations backK011879 3A Dental Implant SystemOsseco Biosource, Ltd. · 2002
- 11 generations backK051576 Avana Dental Implant SystemOsstem Co., Ltd. · 2005
- 10 generations backK062051 SS SystemOsstem Implant Co., Ltd. · 2006
- 9 generations backK063861 GS SystemOsstem Implant Co., Ltd. · 2007
- 8 generations backK073247 US/SS/GS SystemOsstem Implant Co., Ltd. · 2008
- 7 generations backK081575 HU/HS/HG Prosthetic SystemOsstem Implant Co., Ltd. · 2008
- 6 generations backK100245 HS/HG Prosthetic SystemOsstem Implant Co., Ltd. · 2010
- 5 generations backK110308 Prosthetic SystemOsstem Implant Co., Ltd. · 2011
- 4 generations backK123755 Multi Angled AbutmentOsstem Implant Co., Ltd. · 2013
- 3 generations backK132067 Multi Angled Abutment SystemHiossen, Inc. · 2013
- 2 generations backK160670 ET US SS Prosthetic systemOsstem Implant Co., Ltd. · 2017
- 1 generation backK182091 Osstem Abutment SystemOsstem Implant Co., Ltd. · 2019
- This deviceK211090 ZENEX Implant SystemIzenimplant Co., Ltd. · 2022
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd. · 2026 · cites it directly1descendant
- K2314268plant Implant SystemHoowon Edi Co., Ltd. · 2024 · cites it directly1descendant
- K231753Oneday Implant AbutmentOneday Biotech Co., Ltd. · 2024 · cites it directly1descendant
- K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd. · 2026 · 2 generations on0descendants
- K251605DIMPLO Implant SystemDIMPLO, Ltd. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −14 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −13 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −12 | K011879 | 3A Dental Implant System | Osseco Biosource, Ltd. | 2002 | — |
| −11 | K051576 | Avana Dental Implant System | Osstem Co., Ltd. | 2005 | — |
| −10 | K062051 | SS System | Osstem Implant Co., Ltd. | 2006 | — |
| −9 | K063861 | GS System | Osstem Implant Co., Ltd. | 2007 | — |
| −8 | K073247 | US/SS/GS System | Osstem Implant Co., Ltd. | 2008 | — |
| −7 | K081575 | HU/HS/HG Prosthetic System | Osstem Implant Co., Ltd. | 2008 | — |
| −6 | K100245 | HS/HG Prosthetic System | Osstem Implant Co., Ltd. | 2010 | — |
| −5 | K110308 | Prosthetic System | Osstem Implant Co., Ltd. | 2011 | — |
| −4 | K123755 | Multi Angled Abutment | Osstem Implant Co., Ltd. | 2013 | — |
| −3 | K132067 | Multi Angled Abutment System | Hiossen, Inc. | 2013 | — |
| −2 | K160670 | ET US SS Prosthetic system | Osstem Implant Co., Ltd. | 2017 | — |
| −1 | K182091 | Osstem Abutment System | Osstem Implant Co., Ltd. | 2019 | — |
| 0 (this device) | K211090 | ZENEX Implant System | Izenimplant Co., Ltd. | 2022 | — |
| +1 | K252585 | ZENEX Implant System_R-System | Izenimplant Co., Ltd. | 2026 | — |
| +1 | K231426 | 8plant Implant System | Hoowon Edi Co., Ltd. | 2024 | — |
| +1 | K231753 | Oneday Implant Abutment | Oneday Biotech Co., Ltd. | 2024 | — |
| +2 | K253334 | ZENEX Implant System_Short (R-System) | Izenimplant Co., Ltd. | 2026 | — |
| +2 | K251605 | DIMPLO Implant System | DIMPLO, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 5 | 0 |
| 1990 | 6 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 12 | 0 |
| 1994 | 10 | 0 |
| 1995 | 10 | 0 |
| 1996 | 14 | 0 |
| 1997 | 8 | 0 |
| 1998 | 7 | 0 |
| 1999 | 10 | 0 |
| 2000 | 5 | 0 |
| 2001 | 10 | 0 |
| 2002 | 18 | 0 |
| 2003 | 13 | 0 |
| 2004 | 10 | 0 |
| 2005 | 8 | 0 |
| 2006 | 9 | 0 |
| 2007 | 13 | 0 |
| 2008 | 12 | 0 |
| 2009 | 6 | 0 |
| 2010 | 8 | 0 |
| 2011 | 6 | 0 |
| 2012 | 6 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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 K240837 TOV Dental Implant Systemscore 22.5 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K161604 | OSSTEM Implant SystemSummary page 4…Review Panel: Dental 4. Predicate Devices 4.1 Primary Predicate No. K Number Manufacturer Trade Name 1 K161604 OSSTEM Implant Co., Ltd. Osstem Implant System 4.2 Reference Device No. K Number… | 2016 |
| * | K182091 | Osstem Abutment SystemSummary page 4…lant Co., Ltd. Osstem Implant System 4.2 Reference Device No. K Number Manufacturer Trade Name 1 K182091 OSSTEM Implant Co., Ltd Osstem Abutment System 2 K181138 Neobiotech Co., Ltd.… | 2019 |
| * | K181138 | IS-III active SystemSummary page 4…r Manufacturer Trade Name 1 K182091 OSSTEM Implant Co., Ltd Osstem Abutment System 2 K181138 Neobiotech Co., Ltd. IS-III Active System 510(K) Summary… | 2018 |
What descends from it? (8)
6 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 32 years and passes through 8 companies; a new generation was cleared every 1.6 years on median.
- 25 of the 240 ancestors have a recall of any class.
- Of its descendants, K252585 (Izenimplant Co., Ltd., 2026) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K161604.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
ZENEX Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. Wide Fixture System is intended to be used in the molar region
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K211090 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211090: ZENEX 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/K211090
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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