510(k) · Cleared
ClearedZENEX Implant System_R-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 Jan 8, 2026 as substantially equivalent to K211090 (Izenimplant Co., Ltd., 2022) and 4 other predicates after a 146-day review. Its family tree reaches back 19 generations to 1996. 1 later device descends from it.
- Decided
- Jan 8, 2026
- Review
- 146 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 19 generations to K960026 (1996). 420 ancestors in all, the oldest K781060 (1978). 1 later device descends from it, 1 citing it directly.
- Root · 19 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 15 generations between
- 3 generations backK173908 DESS Dental Smart SolutionsTerrats Medical SL · 2018
- 2 generations backK191986 DESS Dental Smart SolutionsTerrats Medical SL · 2019
- 1 generation backK203240 AccelX AbutmentsIntegrated Dental Systems, LLC · 2021
- This deviceK252585 ZENEX Implant System_R-SystemIzenimplant Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK253334 ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd. · 2026
Show all 19 generations
- Root · 19 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 18 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 17 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 16 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 15 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 14 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 13 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 12 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 11 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 10 generations backK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
- 9 generations backK081653 Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · Recalled
- 8 generations backK123022 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013
- 7 generations backK133510 Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014
- 6 generations backK133592 Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua…Neodent USA, Inc. · 2014
- 5 generations backK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
- 4 generations backK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- 3 generations backK173908 DESS Dental Smart SolutionsTerrats Medical SL · 2018
- 2 generations backK191986 DESS Dental Smart SolutionsTerrats Medical SL · 2019
- 1 generation backK203240 AccelX AbutmentsIntegrated Dental Systems, LLC · 2021
- This deviceK252585 ZENEX Implant System_R-SystemIzenimplant Co., Ltd. · 2026
Most influential descendants
Showing 1 of 1 · See all- K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −18 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −17 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −16 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −15 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −14 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −13 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −12 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −11 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −10 | K063364 | Alpha Bio Dental Implant System | Alpha-Bio Tec, Ltd. | 2007 | — |
| −9 | K081653 | Mdi Mii One-Piece Implant, 2.9MM | Imtec Corp. | 2008 | 1 |
| −8 | K123022 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2013 | — |
| −7 | K133510 | Neodent Implant System | Jj Industria E Comercio DE Materiais Dentarios SA | 2014 | — |
| −6 | K133592 | Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart… | Neodent USA, Inc. | 2014 | — |
| −5 | K150367 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2015 | — |
| −4 | K170588 | DESS Dental Smart Solutions | Terrats Medical SL | 2017 | — |
| −3 | K173908 | DESS Dental Smart Solutions | Terrats Medical SL | 2018 | — |
| −2 | K191986 | DESS Dental Smart Solutions | Terrats Medical SL | 2019 | — |
| −1 | K203240 | AccelX Abutments | Integrated Dental Systems, LLC | 2021 | — |
| 0 (this device) | K252585 | ZENEX Implant System_R-System | Izenimplant Co., Ltd. | 2026 | — |
| +1 | K253334 | ZENEX Implant System_Short (R-System) | Izenimplant Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 5 | 0 |
| 1990 | 7 | 0 |
| 1991 | 3 | 0 |
| 1992 | 5 | 0 |
| 1993 | 14 | 0 |
| 1994 | 14 | 0 |
| 1995 | 15 | 0 |
| 1996 | 17 | 0 |
| 1997 | 7 | 0 |
| 1998 | 8 | 0 |
| 1999 | 12 | 0 |
| 2000 | 11 | 0 |
| 2001 | 18 | 0 |
| 2002 | 20 | 0 |
| 2003 | 19 | 0 |
| 2004 | 21 | 0 |
| 2005 | 18 | 0 |
| 2006 | 26 | 0 |
| 2007 | 32 | 0 |
| 2008 | 29 | 0 |
| 2009 | 18 | 0 |
| 2010 | 16 | 0 |
| 2011 | 15 | 0 |
| 2012 | 12 | 0 |
| 2013 | 7 | 0 |
| 2014 | 7 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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? (5)
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 |
|---|---|---|---|
| * | K211090 | ZENEX Implant SystemSummary page 5…: Class II • Date Prepared: 01/07/2026 Predicate Devices: The subject device is substantially equivalent to the following predicate devices: Primary Predicate • K211090, Zenex Implant System manufactured by Izenimplant Co., Ltd. Reference Predicates • K140091, Xpeed AnyRidge Internal Implant S… | 2022 |
| * | K181138 | IS-III active SystemSummary page 5…, Zenex Implant System manufactured by Izenimplant Co., Ltd. Reference Predicates • K140091, Xpeed AnyRidge Internal Implant System by MegaGen Implant Co., Ltd. • K181138, IS-III active System by Neobiotech Co., Ltd. • K203240, AccelX™ Abutments by Integrated Dental Systems • K210826, Healing… | 2018 |
| * | K203240 | AccelX AbutmentsSummary page 5…. Reference Predicates • K140091, Xpeed AnyRidge Internal Implant System by MegaGen Implant Co., Ltd. • K181138, IS-III active System by Neobiotech Co., Ltd. • K203240, AccelX™ Abutments by Integrated Dental Systems • K210826, Healing Abutment, Cover Screw by Megagen Implant Co., Ltd. • K23… | 2021 |
| * | K210826 | Healing Abutment, Cover ScrewSummary page 5…Implant System by MegaGen Implant Co., Ltd. • K181138, IS-III active System by Neobiotech Co., Ltd. • K203240, AccelX™ Abutments by Integrated Dental Systems • K210826, Healing Abutment, Cover Screw by Megagen Implant Co., Ltd. • K231557, ZENEX Implant System_FreeMilling & CCM Cast Abutment by… | 2022 |
| * | K231557 | ZENEX FreeMilling & CCM Cast AbutmentSummary page 5…System by Neobiotech Co., Ltd. • K203240, AccelX™ Abutments by Integrated Dental Systems • K210826, Healing Abutment, Cover Screw by Megagen Implant Co., Ltd. • K231557, ZENEX Implant System_FreeMilling & CCM Cast Abutment by Izen Implant Co., Ltd. Indications for Use: ZENEX Implant System_R-Syst… | 2023 |
| † | K140091 | Xpeed Anyridge Internal Implant Sysyem | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253334 | ZENEX Implant System_Short (R-System) | 2026 | 0 |
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 30 years and passes through 9 companies; a new generation was cleared every 10 months on median.
- 53 of the 420 ancestors have a recall of any class.
- Of its descendants, K253334 (Izenimplant Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K211090.
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?
ZENEX Implant System_R-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 as stated in the FDA summary.
https://510kreport.com/device/K252585 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252585: ZENEX Implant System_R-System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252585
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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