510(k) · Cleared
ClearedBranemark System Estheticone Abutment Complete
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nobelpharma USA, Inc. · DZE Implant, Endosseous, Root-Form
Cleared on Apr 14, 1993 after a 149-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 125 later devices descend from it.
- Decided
- Apr 14, 1993
- Review
- 149 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 0
125 later devices descend from it, 4 citing it directly.
- This deviceK925777 Branemark System Estheticone Abutment CompleteNobelpharma USA, Inc. · 1993
- Descendant · cites it directly · 91 of its ownK041655 Bio Plant System (Implants and Abutments)Cowellmedi Co., Ltd. · 2004
- Descendant · cites it directly · 84 of its ownK052369 Exfeel Implant SystemMegagen Co., Ltd. · 2006
- Descendant · 2 generations on · 74 of its ownK070562 EZ Plus Implant SystemMegagen Co., Ltd. · 2007
- Descendant · 3 generations on · 43 of its ownK110955 Anyridge Internal Implant SystemMegagen Co., Ltd. · 2011
- Descendant · cites it directly · 36 of its ownK020617 Nsi Hexed and Non-Hexed Implant SystemNsi · 2002
Showing 5 of 125 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 125 · See all- K041655Bio Plant System (Implants and Abutments)Cowellmedi Co., Ltd. · 2004 · cites it directly91descendants
- K052369Exfeel Implant SystemMegagen Co., Ltd. · 2006 · cites it directly84descendants
- K070562EZ Plus Implant SystemMegagen Co., Ltd. · 2007 · 2 generations on74descendants
- K110955Anyridge Internal Implant SystemMegagen Co., Ltd. · 2011 · 3 generations on43descendants
- K020617Nsi Hexed and Non-Hexed Implant SystemNsi · 2002 · cites it directly36descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K925777 | Branemark System Estheticone Abutment Complete | Nobelpharma USA, Inc. | 1993 | — |
| +1 | K041655 | Bio Plant System (Implants and Abutments) | Cowellmedi Co., Ltd. | 2004 | — |
| +1 | K052369 | Exfeel Implant System | Megagen Co., Ltd. | 2006 | — |
| +2 | K070562 | EZ Plus Implant System | Megagen Co., Ltd. | 2007 | — |
| +3 | K110955 | Anyridge Internal Implant System | Megagen Co., Ltd. | 2011 | — |
| +1 | K020617 | Nsi Hexed and Non-Hexed Implant System | Nsi | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 4 | 0 |
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 6 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 7 | 0 |
| 2017 | 7 | 0 |
| 2018 | 8 | 0 |
| 2019 | 4 | 0 |
| 2020 | 10 | 0 |
| 2021 | 12 | 0 |
| 2022 | 8 | 0 |
| 2023 | 14 | 0 |
| 2024 | 10 | 0 |
| 2025 | 7 | 0 |
| 2026 | 5 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (125)
See all 1254 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?
- Of its descendants, K041655 (Cowellmedi Co., Ltd., 2004) has gone furthest, with 91 descendants of its own.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K925777 · printed Nov 4, 2026
Cite this page
510(k) Report. “K925777: Branemark System Estheticone Abutment Complete.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K925777
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026