510(k) · Cleared
ClearedBranemark System (R) - 5.5MM Fixture
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 Oct 5, 1993 after a 280-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 30 later devices descend from it.
- Decided
- Oct 5, 1993
- Review
- 280 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 0
30 later devices descend from it, 2 citing it directly.
- This deviceK926501 Branemark System (R) - 5.5MM FixtureNobelpharma USA, Inc. · 1993
- Descendant · cites it directly · 27 of its ownK955281 Endosseous Dental Implant & AccessoriesThe Straumann Co. · 1996
- Descendant · 2 generations on · 24 of its ownK061169 Endosseous Dental ImplantNorthern Implants, LLC · 2006
- Descendant · 3 generations on · 21 of its ownK070841 Endosseous Dental Implant SystemSouthern Implants, Inc. · 2007
- Descendant · 3 generations on · 17 of its ownK070905 Endosseous Dental Implant SystemSouthern Implants, Inc. · 2007 · Recalled
- Descendant · 4 generations on · 13 of its ownK163634 External Hex ImplantsSouthern Implants (Pty), Ltd. · 2017 · Recalled
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K955281Endosseous Dental Implant & AccessoriesThe Straumann Co. · 1996 · cites it directly27descendants
- K061169Endosseous Dental ImplantNorthern Implants, LLC · 2006 · 2 generations on24descendants
- K070841Endosseous Dental Implant SystemSouthern Implants, Inc. · 2007 · 3 generations on21descendants
- K070905Endosseous Dental Implant SystemSouthern Implants, Inc. · 2007 · 3 generations on17descendants
- K163634External Hex ImplantsSouthern Implants (Pty), Ltd. · 2017 · 4 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K926501 | Branemark System (R) - 5.5MM Fixture | Nobelpharma USA, Inc. | 1993 | — |
| +1 | K955281 | Endosseous Dental Implant & Accessories | The Straumann Co. | 1996 | — |
| +2 | K061169 | Endosseous Dental Implant | Northern Implants, LLC | 2006 | — |
| +3 | K070841 | Endosseous Dental Implant System | Southern Implants, Inc. | 2007 | — |
| +3 | K070905 | Endosseous Dental Implant System | Southern Implants, Inc. | 2007 | 1 |
| +4 | K163634 | External Hex Implants | Southern Implants (Pty), Ltd. | 2017 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 5 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 0 |
| 2026 | 1 | 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? (30)
See all 302 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, K955281 (The Straumann Co., 1996) has gone furthest, with 27 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/K926501 · printed Nov 4, 2026
Cite this page
510(k) Report. “K926501: Branemark System (R) - 5.5MM Fixture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K926501
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026