510(k) · Cleared
ClearedAnyOne External 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 Aug 28, 2021 as substantially equivalent to K122231 (Megagen Implant Co., Ltd., 2012) after a 267-day review. Its family tree reaches back 10 generations to 1995.
- Decided
- Aug 28, 2021
- Review
- 267 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K944964 (1995). 71 ancestors in all, the oldest K874590 (1988). No later device cites it as a predicate yet.
- Root · 10 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 6 generations between
- 3 generations backK070562 EZ Plus Implant SystemMegagen Co., Ltd. · 2007
- 2 generations backK110955 Anyridge Internal Implant SystemMegagen Co., Ltd. · 2011
- 1 generation backK122231 Xpeed Any Ridge Internal Implant SystemMegagen Implant Co., Ltd. · 2012
- This deviceK203554 AnyOne External Implant SystemMegagen Implant Co., Ltd. · 2021
Show all 10 generations
- Root · 10 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 9 generations backK961728 Miruscone Abutment SystemNobelpharma USA, Inc. · 1996
- 8 generations backK962403 Noblepharma Wide AccessoriesNobelpharma USA, Inc. · 1996
- 7 generations backK971706 Tiadapt Abutment SystemNobel Biocare Uas, Inc. · 1997
- 6 generations backK974150 Procera Preparable Abutment SystemNobel Biocare Uas, Inc. · 1998 · Recalled
- 5 generations backK041655 Bio Plant System (Implants and Abutments)Cowellmedi Co., Ltd. · 2004
- 4 generations backK052369 Exfeel Implant SystemMegagen Co., Ltd. · 2006
- 3 generations backK070562 EZ Plus Implant SystemMegagen Co., Ltd. · 2007
- 2 generations backK110955 Anyridge Internal Implant SystemMegagen Co., Ltd. · 2011
- 1 generation backK122231 Xpeed Any Ridge Internal Implant SystemMegagen Implant Co., Ltd. · 2012
- This deviceK203554 AnyOne External Implant SystemMegagen Implant Co., Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K944964 | Branemark System Miruscone Abutment System | Nobelpharma USA, Inc. | 1995 | — |
| −9 | K961728 | Miruscone Abutment System | Nobelpharma USA, Inc. | 1996 | — |
| −8 | K962403 | Noblepharma Wide Accessories | Nobelpharma USA, Inc. | 1996 | — |
| −7 | K971706 | Tiadapt Abutment System | Nobel Biocare Uas, Inc. | 1997 | — |
| −6 | K974150 | Procera Preparable Abutment System | Nobel Biocare Uas, Inc. | 1998 | 2 |
| −5 | K041655 | Bio Plant System (Implants and Abutments) | Cowellmedi Co., Ltd. | 2004 | — |
| −4 | K052369 | Exfeel Implant System | Megagen Co., Ltd. | 2006 | — |
| −3 | K070562 | EZ Plus Implant System | Megagen Co., Ltd. | 2007 | — |
| −2 | K110955 | Anyridge Internal Implant System | Megagen Co., Ltd. | 2011 | — |
| −1 | K122231 | Xpeed Any Ridge Internal Implant System | Megagen Implant Co., Ltd. | 2012 | — |
| 0 (this device) | K203554 | AnyOne External Implant System | Megagen Implant Co., Ltd. | 2021 | — |
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 |
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 |
|---|---|---|---|
| * | K122231 | Xpeed Any Ridge Internal Implant SystemSummary page 4…NHA ƒ Classification regulation: Class II, 21 CFR 872.3640 4. Predicate Device ƒ Primary Predicate Device: K122231 - Xpeed AnyRidge Internal Implant System ƒ Reference Devices: K052369 - ExFeel Dental Implant System… | 2012 |
| † | K052369 | Exfeel Implant System | 2006 |
| † | K123988 | Anyonetm Internal Implant System | 2013 |
| † | K192347 | ST Internal Implant System | 2019 |
| † | K053353 | Rescue Implant System | 2006 |
| † | K182448 | AnyRidge Octa 1 Implant System | 2019 |
| † | K150537 | MiNi Internal Implant System | 2015 |
| † | K192436 | Healing Abutments and Cover Screws | 2020 |
| † | K110955 | Anyridge Internal Implant System | 2011 |
| † | K081302 | Rescue External Implant System | 2008 |
| † | K160670 | ET US SS Prosthetic system | 2017 |
| † | K171142 | Healing Cap Multi-Unit Titanium | 2017 |
| † | K182091 | Osstem Abutment System | 2019 |
| † | K192614 | Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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 5 companies; a new generation was cleared every 1.3 years on median.
- 6 of the 71 ancestors have a recall of any class.
- 4 other devices also cite its predicate K122231.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 AnyOne External 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 6.0 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K203554 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203554: AnyOne External 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/K203554
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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