510(k) · Cleared
ClearedBranemark System Miruscone Abutment System
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 Feb 28, 1995 after a 144-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 633 later devices descend from it.
- Decided
- Feb 28, 1995
- Review
- 144 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 0
633 later devices descend from it, 2 citing it directly.
- This deviceK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- Descendant · cites it directly · 551 of its ownK961728 Miruscone Abutment SystemNobelpharma USA, Inc. · 1996
- Descendant · 2 generations on · 549 of its ownK962403 Noblepharma Wide AccessoriesNobelpharma USA, Inc. · 1996
- Descendant · 3 generations on · 545 of its ownK971706 Tiadapt Abutment SystemNobel Biocare Uas, Inc. · 1997
- Descendant · 4 generations on · 543 of its ownK974150 Procera Preparable Abutment SystemNobel Biocare Uas, Inc. · 1998 · Recalled
- Descendant · 5 generations on · 476 of its ownK032263 3I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc. · 2004 · Recalled
Showing 5 of 633 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 633 · See all- K961728Miruscone Abutment SystemNobelpharma USA, Inc. · 1996 · cites it directly551descendants
- K962403Noblepharma Wide AccessoriesNobelpharma USA, Inc. · 1996 · 2 generations on549descendants
- K971706Tiadapt Abutment SystemNobel Biocare Uas, Inc. · 1997 · 3 generations on545descendants
- K974150Procera Preparable Abutment SystemNobel Biocare Uas, Inc. · 1998 · 4 generations on543descendants
- K0322633I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc. · 2004 · 5 generations on476descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K944964 | Branemark System Miruscone Abutment System | Nobelpharma USA, Inc. | 1995 | — |
| +1 | K961728 | Miruscone Abutment System | Nobelpharma USA, Inc. | 1996 | — |
| +2 | K962403 | Noblepharma Wide Accessories | Nobelpharma USA, Inc. | 1996 | — |
| +3 | K971706 | Tiadapt Abutment System | Nobel Biocare Uas, Inc. | 1997 | — |
| +4 | K974150 | Procera Preparable Abutment System | Nobel Biocare Uas, Inc. | 1998 | 2 |
| +5 | K032263 | 3I Patient-Specific Dental Abutment and Overdenture Bar | Implant Innovations, Inc. | 2004 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 2004 | 13 | 0 |
| 2005 | 9 | 0 |
| 2006 | 17 | 0 |
| 2007 | 10 | 0 |
| 2008 | 13 | 0 |
| 2009 | 19 | 0 |
| 2010 | 11 | 0 |
| 2011 | 20 | 0 |
| 2012 | 16 | 0 |
| 2013 | 17 | 0 |
| 2014 | 21 | 0 |
| 2015 | 29 | 0 |
| 2016 | 35 | 0 |
| 2017 | 28 | 0 |
| 2018 | 29 | 0 |
| 2019 | 28 | 0 |
| 2020 | 46 | 0 |
| 2021 | 43 | 0 |
| 2022 | 38 | 0 |
| 2023 | 46 | 0 |
| 2024 | 64 | 0 |
| 2025 | 45 | 0 |
| 2026 | 28 | 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (633)
See all 6332 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, K961728 (Nobelpharma USA, Inc., 1996) has gone furthest, with 551 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/K944964 · printed Nov 4, 2026
Cite this page
510(k) Report. “K944964: Branemark System Miruscone Abutment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K944964
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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