510(k) · Cleared
ClearedXive Dental Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Friadent GmbH · DZE Implant, Endosseous, Root-Form
Cleared on Mar 15, 2002 after a 114-day review. The summary cites 2 numbers, none of which could be confirmed as its predicate (see the table below). 570 later devices descend from it.
- Decided
- Mar 15, 2002
- Review
- 114 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
570 later devices descend from it, 6 citing it directly.
- This deviceK013867 Xive Dental Implant SystemFriadent GmbH · 2002
- Descendant · cites it directly · 547 of its ownK021318 Xive Dental Implant SystemFriadent GmbH · 2002
- Descendant · cites it directly · 542 of its ownK032158 Xive Dental Implant System MultipleFriadent GmbH · 2003
- Descendant · cites it directly · 425 of its ownK024004 Xive Transgingival Dental Implant SystemFriadent GmbH · 2003
- Descendant · 2 generations on · 394 of its ownK032284 Xive TG Dental Implant SystemFriadent GmbH · 2003
- Descendant · 2 generations on · 376 of its ownK033984 Straumann Dental Implant SystemInstitut Straumann AG · 2004
Showing 5 of 570 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 570 · See all- K021318Xive Dental Implant SystemFriadent GmbH · 2002 · cites it directly547descendants
- K032158Xive Dental Implant System MultipleFriadent GmbH · 2003 · cites it directly542descendants
- K024004Xive Transgingival Dental Implant SystemFriadent GmbH · 2003 · cites it directly425descendants
- K032284Xive TG Dental Implant SystemFriadent GmbH · 2003 · 2 generations on394descendants
- K033984Straumann Dental Implant SystemInstitut Straumann AG · 2004 · 2 generations on376descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K013867 | Xive Dental Implant System | Friadent GmbH | 2002 | — |
| +1 | K021318 | Xive Dental Implant System | Friadent GmbH | 2002 | — |
| +1 | K032158 | Xive Dental Implant System Multiple | Friadent GmbH | 2003 | — |
| +1 | K024004 | Xive Transgingival Dental Implant System | Friadent GmbH | 2003 | — |
| +2 | K032284 | Xive TG Dental Implant System | Friadent GmbH | 2003 | — |
| +2 | K033984 | Straumann Dental Implant System | Institut Straumann AG | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 4 | 0 |
| 2004 | 4 | 0 |
| 2005 | 4 | 0 |
| 2006 | 6 | 0 |
| 2007 | 5 | 0 |
| 2008 | 11 | 0 |
| 2009 | 6 | 0 |
| 2010 | 10 | 0 |
| 2011 | 12 | 0 |
| 2012 | 19 | 0 |
| 2013 | 22 | 0 |
| 2014 | 24 | 0 |
| 2015 | 31 | 0 |
| 2016 | 31 | 0 |
| 2017 | 27 | 0 |
| 2018 | 29 | 0 |
| 2019 | 27 | 0 |
| 2020 | 41 | 0 |
| 2021 | 39 | 0 |
| 2022 | 38 | 0 |
| 2023 | 50 | 0 |
| 2024 | 57 | 0 |
| 2025 | 48 | 0 |
| 2026 | 24 | 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? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K925765 | FDA’s K925765 is Branemark System Standard 3.75MM Fixture Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1993 |
| Kept off the family tree | K934584 | FDA’s K934584 is Spectrolyse Factor Vii:C Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1993 |
What descends from it? (570)
See all 5706 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, K021318 (Friadent GmbH, 2002) has gone furthest, with 547 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 XiVE Dental Implant System is indicated as follows:
Once the implant has osseointegrated, it serves to support
single tooth, bridge and overdenture restorations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K013867 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013867: Xive Dental Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013867
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026