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 Jul 2, 2002 as substantially equivalent to K013867 (Friadent GmbH, 2002) and 1 other predicate after a 68-day review. Its family tree reaches back 4 generations to 1990. 547 later devices descend from it.
- Decided
- Jul 2, 2002
- Review
- 68 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K894595 (1990). 14 ancestors in all. 547 later devices descend from it, 7 citing it directly.
- Root · 4 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 3 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 2 generations backK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
- 1 generation backK013067 Frialoc Dental Implant SystemFriadent GmbH · 2002
- This deviceK021318 Xive Dental Implant SystemFriadent GmbH · 2002
- Descendant · cites it directly · 542 of its ownK032158 Xive Dental Implant System MultipleFriadent GmbH · 2003
- Descendant · 2 generations on · 376 of its ownK033984 Straumann Dental Implant SystemInstitut Straumann AG · 2004
- Descendant · cites it directly · 325 of its ownK041509 Ankylos Dental Implant SystemFriadent GmbH · 2004
- Descendant · 3 generations on · 295 of its ownK053088 Slactive ImplantsInstitut Straumann AG · 2006
- Descendant · 2 generations on · 290 of its ownK083805 Ankylos C/X Dental Implant SystemDentsply Intl., Inc. · 2009
Showing 5 of 547 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 547 · See all- K032158Xive Dental Implant System MultipleFriadent GmbH · 2003 · cites it directly542descendants
- K033984Straumann Dental Implant SystemInstitut Straumann AG · 2004 · 2 generations on376descendants
- K041509Ankylos Dental Implant SystemFriadent GmbH · 2004 · cites it directly325descendants
- K053088Slactive ImplantsInstitut Straumann AG · 2006 · 3 generations on295descendants
- K083805Ankylos C/X Dental Implant SystemDentsply Intl., Inc. · 2009 · 2 generations on290descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −3 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −2 | K992937 | Dental Implant | Nobel Biocare Uas, Inc. | 2000 | 1 |
| −1 | K013067 | Frialoc Dental Implant System | Friadent GmbH | 2002 | — |
| 0 (this device) | K021318 | Xive Dental Implant System | Friadent GmbH | 2002 | — |
| +1 | K032158 | Xive Dental Implant System Multiple | Friadent GmbH | 2003 | — |
| +2 | K033984 | Straumann Dental Implant System | Institut Straumann AG | 2004 | — |
| +1 | K041509 | Ankylos Dental Implant System | Friadent GmbH | 2004 | — |
| +3 | K053088 | Slactive Implants | Institut Straumann AG | 2006 | — |
| +2 | K083805 | Ankylos C/X Dental Implant System | Dentsply Intl., Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 2 | 0 |
| 2008 | 10 | 0 |
| 2009 | 6 | 0 |
| 2010 | 10 | 0 |
| 2011 | 10 | 0 |
| 2012 | 17 | 0 |
| 2013 | 20 | 0 |
| 2014 | 23 | 0 |
| 2015 | 30 | 0 |
| 2016 | 31 | 0 |
| 2017 | 27 | 0 |
| 2018 | 28 | 0 |
| 2019 | 26 | 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.
What descends from it? (547)
See all 5477 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032158 | Xive Dental Implant System Multiple | 2003 | 542 |
| K041509 | Ankylos Dental Implant System | 2004 | 325 |
| K060958 | Straumann Narrow Neck Implants | 2006 | 228 |
| K063106 | Revois Implant System | 2007 | 2 |
| K141188 | Microdent Genius Implant System | 2015 | 0 |
| K073622 | Easy Grip Dental Implant System | 2008 | 0 |
| K042971 | Titan Dental Implant System | 2005 | 0 |
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?
- The line of descent spans 12 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- 2 of the 14 ancestors have a recall of any class.
- Of its descendants, K032158 (Friadent GmbH, 2003) has gone furthest, with 542 descendants of its own.
- 5 other devices also cite its predicate K013867.
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 for the following:
Once the implant has osseointegrated, it serves to support single tooth, bridge and overdenture restorations.
In the edentulous mandible, a minimum of four XiVE dental implants (2 9Smm length) are placed between the mental foramina and rigidly splinted together. In this case, bar-prosthetic loading is possible immediately after implant placement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021318 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021318: 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/K021318
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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