510(k) · Cleared
ClearedVarious Branemark System Implants-Immediate Function Indication
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nobel Biocare AB · DZE Implant, Endosseous, Root-Form
Cleared on Oct 11, 2002 after a 70-day review. The FDA summary names no predicate by number. 929 later devices descend from it.
- Decided
- Oct 11, 2002
- Review
- 70 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 0
929 later devices descend from it, 19 citing it directly.
- This deviceK022562 Various Branemark System Implants-Immediate Function IndicationNobel Biocare AB · 2002
- Descendant · cites it directly · 622 of its ownK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- Descendant · cites it directly · 570 of its ownK030007 Iti Dental Implant SystemStraumann USA · 2003
- Descendant · 2 generations on · 532 of its ownK050705 Tiunite ImplantsNobel Biocare AB · 2005 · Recalled
- Descendant · 2 generations on · 511 of its ownK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- Descendant · 3 generations on · 507 of its ownK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
Showing 5 of 929 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 929 · See all- K041661Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004 · cites it directly622descendants
- K030007Iti Dental Implant SystemStraumann USA · 2003 · cites it directly570descendants
- K050705Tiunite ImplantsNobel Biocare AB · 2005 · 2 generations on532descendants
- K050258Groovy ImplantsNobel Biocare AB · 2005 · 2 generations on511descendants
- K061003SFB & CFB ImplantsNobel Biocare AB · 2006 · 3 generations on507descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K022562 | Various Branemark System Implants-Immediate Function Indication | Nobel Biocare AB | 2002 | — |
| +1 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| +1 | K030007 | Iti Dental Implant System | Straumann USA | 2003 | — |
| +2 | K050705 | Tiunite Implants | Nobel Biocare AB | 2005 | 1 |
| +2 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| +3 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2004 | 13 | 0 |
| 2005 | 13 | 0 |
| 2006 | 15 | 0 |
| 2007 | 21 | 0 |
| 2008 | 21 | 0 |
| 2009 | 24 | 0 |
| 2010 | 22 | 0 |
| 2011 | 29 | 0 |
| 2012 | 36 | 0 |
| 2013 | 48 | 0 |
| 2014 | 43 | 0 |
| 2015 | 48 | 0 |
| 2016 | 51 | 0 |
| 2017 | 48 | 0 |
| 2018 | 44 | 0 |
| 2019 | 43 | 0 |
| 2020 | 60 | 0 |
| 2021 | 54 | 0 |
| 2022 | 55 | 0 |
| 2023 | 68 | 0 |
| 2024 | 76 | 0 |
| 2025 | 62 | 0 |
| 2026 | 33 | 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?
The FDA summary names no predicate by number.
What descends from it? (929)
See all 92919 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041661 | Nobel Biocare Endosseous Implants | 2004 | 622 |
| K030007 | Iti Dental Implant System | 2003 | 570 |
| K041492 | Astra Tech Implants - Dental System | 2004 | 360 |
| K041236 | Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052 | 2004 | 328 |
| K030614 | 3I Dental Implants | 2003 | 319 |
| K073075 | Frialit Plus, Xive S Plus, Xive TG Plus, Ankylos Plus, Dental Implant Systems | 2008 | 304 |
| K030685 | Teeth in an Hour - Ark Implant Concept | 2004 | 259 |
| K060958 | Straumann Narrow Neck Implants | 2006 | 228 |
| K041876 | Nobeldirect OD Implant | 2004 | 188 |
| K063364 | Alpha Bio Dental Implant System | 2007 | 187 |
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, K041661 (Nobel Biocare Uas, Inc., 2004) has gone furthest, with 622 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 | — |
What is it indicated for?
The Brhemark System implants are for single-stage or two-stage surgical procedures and cement or screw retained restorations. The Brinemark System implants are intended for immediate placement and hnction on single tooth and/or multiple tooth applications recognizing sufficient bone stability (type I or II bone) and appropriate occlusal loading, to restore chewing fitnction. Multiple tooth applications may be splinted with a bar.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022562 · printed Nov 5, 2026
Cite this page
510(k) Report. “K022562: Various Branemark System Implants-Immediate Function Indication.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K022562
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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