510(k) · Cleared
ClearedARi ExCon Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Megagen Implant Co., Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Dec 7, 2023 as substantially equivalent to K163634 (Southern Implants (Pty), Ltd., 2017) after a 157-day review. Its family tree reaches back 14 generations to 1993. 1 later device descends from it.
- Decided
- Dec 7, 2023
- Review
- 157 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K925765 (1993). 217 ancestors in all, the oldest K781060 (1978). 1 later device descends from it, 1 citing it directly.
- Root · 14 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 10 generations between
- 3 generations backK111216 Osseotite 2 Dental ImplantsBiomet 3i, Inc. · 2011
- 2 generations backK133049 3I T3(R) External Hex Dental ImplantsBiomet 3i · 2014
- 1 generation backK163634 External Hex ImplantsSouthern Implants (Pty), Ltd. · 2017 · Recalled
- This deviceK231967 ARi ExCon Implant SystemMegagen Implant Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK241972 Bluediamond ImplantMegagen Implant Co., Ltd. · 2024
Show all 14 generations
- Root · 14 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 13 generations backK994376 Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating…Friadent GmbH · 2000
- 12 generations backK014235 Osseotite NT Dental Implants & AccessoriesImplant Innovations, Inc. · 2002
- 11 generations backK022009 3I Implants; Osseotite Dental Implants; Osseotite NT Dental ImplantsImplant Innovations, Inc. · 2002
- 10 generations backK031475 Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2003
- 9 generations backK041402 Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc. · 2004
- 8 generations backK051189 Prevail Dental ImplantsImplant Innovations, Inc. · 2005
- 7 generations backK051461 3I Osseotite Dental ImplantsImplant Innovations, Inc. · 2005
- 6 generations backK062432 Nanotite Dental ImplantsImplant Innovations, Inc. · 2007
- 5 generations backK062636 Osseotite, Osseotite NY, Certain, Certain NT, Prevail, Certain…Implant Innovations, Inc. · 2007
- 4 generations backK100724 Osseotite II Model XifossxxxBiomet 3i, Inc. · 2011 · Recalled
- 3 generations backK111216 Osseotite 2 Dental ImplantsBiomet 3i, Inc. · 2011
- 2 generations backK133049 3I T3(R) External Hex Dental ImplantsBiomet 3i · 2014
- 1 generation backK163634 External Hex ImplantsSouthern Implants (Pty), Ltd. · 2017 · Recalled
- This deviceK231967 ARi ExCon Implant SystemMegagen Implant Co., Ltd. · 2023
Most influential descendants
Showing 1 of 1 · See all- K241972Bluediamond ImplantMegagen Implant Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K925765 | Branemark System Standard 3.75MM Fixture | Nobelpharma USA, Inc. | 1993 | — |
| −13 | K994376 | Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2… | Friadent GmbH | 2000 | — |
| −12 | K014235 | Osseotite NT Dental Implants & Accessories | Implant Innovations, Inc. | 2002 | — |
| −11 | K022009 | 3I Implants; Osseotite Dental Implants; Osseotite NT Dental Implants | Implant Innovations, Inc. | 2002 | — |
| −10 | K031475 | Osseotite NT Certain Implants | Implant Innovations, Inc. | 2003 | — |
| −9 | K041402 | Modification to Osseotite NT Certain Implants | Implant Innovations, Inc. | 2004 | — |
| −8 | K051189 | Prevail Dental Implants | Implant Innovations, Inc. | 2005 | — |
| −7 | K051461 | 3I Osseotite Dental Implants | Implant Innovations, Inc. | 2005 | — |
| −6 | K062432 | Nanotite Dental Implants | Implant Innovations, Inc. | 2007 | — |
| −5 | K062636 | Osseotite, Osseotite NY, Certain, Certain NT, Prevail, Certain Prevail, XP… | Implant Innovations, Inc. | 2007 | — |
| −4 | K100724 | Osseotite II Model Xifossxxx | Biomet 3i, Inc. | 2011 | 5 |
| −3 | K111216 | Osseotite 2 Dental Implants | Biomet 3i, Inc. | 2011 | — |
| −2 | K133049 | 3I T3(R) External Hex Dental Implants | Biomet 3i | 2014 | — |
| −1 | K163634 | External Hex Implants | Southern Implants (Pty), Ltd. | 2017 | 1 |
| 0 (this device) | K231967 | ARi ExCon Implant System | Megagen Implant Co., Ltd. | 2023 | — |
| +1 | K241972 | Bluediamond Implant | Megagen Implant Co., Ltd. | 2024 | — |
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 | 8 | 0 |
| 1991 | 2 | 0 |
| 1992 | 4 | 0 |
| 1993 | 15 | 0 |
| 1994 | 11 | 0 |
| 1995 | 15 | 0 |
| 1996 | 14 | 0 |
| 1997 | 8 | 0 |
| 1998 | 7 | 0 |
| 1999 | 8 | 0 |
| 2000 | 3 | 0 |
| 2001 | 10 | 0 |
| 2002 | 14 | 0 |
| 2003 | 10 | 0 |
| 2004 | 9 | 0 |
| 2005 | 5 | 0 |
| 2006 | 7 | 0 |
| 2007 | 10 | 0 |
| 2008 | 6 | 0 |
| 2009 | 5 | 0 |
| 2010 | 6 | 0 |
| 2011 | 7 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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? (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 |
|---|---|---|---|
| * | K163634 | External Hex ImplantsSummary page 5…Code: NHA Classification regulation: Class II, 21 CFR 872.3640 4. Predicate Device • Primary Predicate Device: K163634 - External Hex Implants • Reference Device: K210852 - Noris Medical Dental Implants System – Cortical… | 2017 |
| † | K210852 | Noris Medical Dental Implants System - Cortical | 2022 |
| † | K200586 | Straumann TLX Implant System | 2020 |
| † | K203554 | AnyOne External Implant System | 2021 |
| † | K182448 | AnyRidge Octa 1 Implant System | 2019 |
| † | K150537 | MiNi Internal Implant System | 2015 |
| † | K123988 | Anyonetm Internal Implant System | 2013 |
| † | K110955 | Anyridge Internal Implant System | 2011 |
| † | K192347 | ST Internal Implant System | 2019 |
| † | K210161 | AnyOne Onestage Implant System | 2021 |
| † | K220562 | TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment | 2022 |
| † | K122231 | Xpeed Any Ridge Internal Implant System | 2012 |
| † | K230618 | MegaGen Dental Implant Systems Portfolio - MR Conditional | 2023 |
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 |
|---|---|---|---|
| K241972 | Bluediamond Implant | 2024 | 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 7 companies; a new generation was cleared every 1.4 years on median.
- 26 of the 217 ancestors have a recall of any class.
- Of its descendants, K241972 (Megagen Implant Co., Ltd., 2024) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K163634.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 ARi ExCon Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function in the following situations and with the clinical protocols:
- Delayed loading
- Immediate loading when good primary stability is achieved and with appropriate occlusal loading.
For TiGEN Abutment and ZrGEN Abutment, all digitally designed abutments for use with TiGEN Abutment and ZrGEN Abutment are intended to be sent to a MegaGen-validated milling center for manufacture.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231967 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231967: ARi ExCon 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/K231967
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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