510(k) · Cleared
ClearedXpeed Anyridge Internal Implant Sysyem
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 12, 2014 as substantially equivalent to K110955 (Megagen Co., Ltd., 2011) and 1 other predicate after a 332-day review. Its family tree reaches back 9 generations to 1995. 9 later devices descend from it.
- Decided
- Dec 12, 2014
- Review
- 332 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K944964 (1995). 70 ancestors in all, the oldest K874590 (1988). 9 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 5 generations between
- 3 generations backK052369 Exfeel Implant SystemMegagen Co., Ltd. · 2006
- 2 generations backK070562 EZ Plus Implant SystemMegagen Co., Ltd. · 2007
- 1 generation backK110955 Anyridge Internal Implant SystemMegagen Co., Ltd. · 2011
- This deviceK140091 Xpeed Anyridge Internal Implant SysyemMegagen Implant Co., Ltd. · 2014
- Descendant · cites it directly · 5 of its ownK170044 Inclusive Titanium Abutments compatible with: MegaGen AnyRidge…Prismatik Dentalcraft, Inc. · 2017
- Descendant · 2 generations on · 4 of its ownK191222 Inclusive Titanium Abutments compatible with: Dentsply Implants…Prismatik Dentalcraft, Inc. · 2019
- Descendant · cites it directly · 2 of its ownK203240 AccelX AbutmentsIntegrated Dental Systems, LLC · 2021
- Descendant · 2 generations on · 1 of its ownK252585 ZENEX Implant System_R-SystemIzenimplant Co., Ltd. · 2026
- Descendant · 3 generations on · 0 of its ownK253334 ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd. · 2026
Show all 9 generations
- Root · 9 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 8 generations backK961728 Miruscone Abutment SystemNobelpharma USA, Inc. · 1996
- 7 generations backK962403 Noblepharma Wide AccessoriesNobelpharma USA, Inc. · 1996
- 6 generations backK971706 Tiadapt Abutment SystemNobel Biocare Uas, Inc. · 1997
- 5 generations backK974150 Procera Preparable Abutment SystemNobel Biocare Uas, Inc. · 1998 · Recalled
- 4 generations backK041655 Bio Plant System (Implants and Abutments)Cowellmedi Co., Ltd. · 2004
- 3 generations backK052369 Exfeel Implant SystemMegagen Co., Ltd. · 2006
- 2 generations backK070562 EZ Plus Implant SystemMegagen Co., Ltd. · 2007
- 1 generation backK110955 Anyridge Internal Implant SystemMegagen Co., Ltd. · 2011
- This deviceK140091 Xpeed Anyridge Internal Implant SysyemMegagen Implant Co., Ltd. · 2014
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K170044Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant SystemPrismatik Dentalcraft, Inc. · 2017 · cites it directly5descendants
- K191222Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant…Prismatik Dentalcraft, Inc. · 2019 · 2 generations on4descendants
- K203240AccelX AbutmentsIntegrated Dental Systems, LLC · 2021 · cites it directly2descendants
- K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd. · 2026 · 2 generations on1descendant
- K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K944964 | Branemark System Miruscone Abutment System | Nobelpharma USA, Inc. | 1995 | — |
| −8 | K961728 | Miruscone Abutment System | Nobelpharma USA, Inc. | 1996 | — |
| −7 | K962403 | Noblepharma Wide Accessories | Nobelpharma USA, Inc. | 1996 | — |
| −6 | K971706 | Tiadapt Abutment System | Nobel Biocare Uas, Inc. | 1997 | — |
| −5 | K974150 | Procera Preparable Abutment System | Nobel Biocare Uas, Inc. | 1998 | 2 |
| −4 | K041655 | Bio Plant System (Implants and Abutments) | Cowellmedi Co., Ltd. | 2004 | — |
| −3 | K052369 | Exfeel Implant System | Megagen Co., Ltd. | 2006 | — |
| −2 | K070562 | EZ Plus Implant System | Megagen Co., Ltd. | 2007 | — |
| −1 | K110955 | Anyridge Internal Implant System | Megagen Co., Ltd. | 2011 | — |
| 0 (this device) | K140091 | Xpeed Anyridge Internal Implant Sysyem | Megagen Implant Co., Ltd. | 2014 | — |
| +1 | K170044 | Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System | Prismatik Dentalcraft, Inc. | 2017 | — |
| +2 | K191222 | Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech… | Prismatik Dentalcraft, Inc. | 2019 | — |
| +1 | K203240 | AccelX Abutments | Integrated Dental Systems, LLC | 2021 | — |
| +2 | K252585 | ZENEX Implant System_R-System | Izenimplant Co., Ltd. | 2026 | — |
| +3 | K253334 | ZENEX Implant System_Short (R-System) | Izenimplant Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1993 | 10 | 0 |
| 1994 | 5 | 0 |
| 1995 | 5 | 0 |
| 1996 | 7 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 4 | 0 |
| 2000 | 5 | 0 |
| 2001 | 4 | 0 |
| 2002 | 5 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 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 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? (2)
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 |
|---|---|---|---|
| * | K110955 | Anyridge Internal Implant SystemSummary page 6…iate occlusal loading. Larger implants are dedicated for the molar region and are indicated for delayed loading. Predicate devices AnyRidge Internal Implant System (K110955) Straumann Anodized Neck Implants (K061176) Substantial Equivalence Comparison The Xpeed AnyRidge Internal Implant System h… | 2011 |
| * | K061176 | Straumann Dental ImplantsSummary page 6…ated for the molar region and are indicated for delayed loading. Predicate devices AnyRidge Internal Implant System (K110955) Straumann Anodized Neck Implants (K061176) Substantial Equivalence Comparison The Xpeed AnyRidge Internal Implant System has a substantially equivalent intended use as th… | 2006 |
What descends from it? (9)
2 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 19 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 6 of the 70 ancestors have a recall of any class.
- Of its descendants, K170044 (Prismatik Dentalcraft, Inc., 2017) has gone furthest, with 5 descendants of its own.
- 4 other devices also cite its predicate K110955.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Xpeed AnyRidge Internal 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. Smaller implants (less than Ø6.0 mm) are dedicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region and are indicated for delayed loading.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140091 · printed Nov 5, 2026
Cite this page
510(k) Report. “K140091: Xpeed Anyridge Internal Implant Sysyem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140091
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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