510(k) · Cleared
ClearedXive Dental Implant System Multiple
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 Aug 14, 2003 as substantially equivalent to K013867 (Friadent GmbH, 2002) and 1 other predicate after a 30-day review. Its family tree reaches back 5 generations to 1990. 542 later devices descend from it.
- Decided
- Aug 14, 2003
- Review
- 30 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K894595 (1990). 15 ancestors in all. 542 later devices descend from it, 6 citing it directly.
- Root · 5 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 4 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 3 generations backK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
- 2 generations backK013067 Frialoc Dental Implant SystemFriadent GmbH · 2002
- 1 generation backK021318 Xive Dental Implant SystemFriadent GmbH · 2002
- This deviceK032158 Xive Dental Implant System MultipleFriadent GmbH · 2003
- Descendant · cites it directly · 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 · 2 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
- Descendant · cites it directly · 240 of its ownK100152 Sirona Cad/Cam SystemSirona Dental Systems GmbH · 2010
Showing 5 of 542 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 542 · See all- K033984Straumann Dental Implant SystemInstitut Straumann AG · 2004 · cites it directly376descendants
- K041509Ankylos Dental Implant SystemFriadent GmbH · 2004 · cites it directly325descendants
- K053088Slactive ImplantsInstitut Straumann AG · 2006 · 2 generations on295descendants
- K083805Ankylos C/X Dental Implant SystemDentsply Intl., Inc. · 2009 · 2 generations on290descendants
- K100152Sirona Cad/Cam SystemSirona Dental Systems GmbH · 2010 · cites it directly240descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −4 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −3 | K992937 | Dental Implant | Nobel Biocare Uas, Inc. | 2000 | 1 |
| −2 | K013067 | Frialoc Dental Implant System | Friadent GmbH | 2002 | — |
| −1 | K021318 | Xive Dental Implant System | Friadent GmbH | 2002 | — |
| 0 (this device) | K032158 | Xive Dental Implant System Multiple | Friadent GmbH | 2003 | — |
| +1 | K033984 | Straumann Dental Implant System | Institut Straumann AG | 2004 | — |
| +1 | K041509 | Ankylos Dental Implant System | Friadent GmbH | 2004 | — |
| +2 | K053088 | Slactive Implants | Institut Straumann AG | 2006 | — |
| +2 | K083805 | Ankylos C/X Dental Implant System | Dentsply Intl., Inc. | 2009 | — |
| +1 | K100152 | Sirona Cad/Cam System | Sirona Dental Systems GmbH | 2010 | — |
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 |
|---|---|---|
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2008 | 10 | 0 |
| 2009 | 6 | 0 |
| 2010 | 10 | 0 |
| 2011 | 10 | 0 |
| 2012 | 17 | 0 |
| 2013 | 18 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K013867 | Xive Dental Implant SystemSummary page 1…n Name: Endosseous Dental Implants 21 CFR 872.3640 17.3 IDENTIFICATION OF PREDICATE DEVICES Company Device S10(k) No. Date Cleared FRIADENT GmbH XiVE® Dental Implant KO013867 03/15/2002 System FRIADENT GmbH XiVE® Dental Implant K021318 08/02/2002 Implant System 313 FRIADENT GmbH XiW@De… | 2002 |
| * | K021318 | Xive Dental Implant SystemSummary page 1…TIFICATION OF PREDICATE DEVICES Company Device S10(k) No. Date Cleared FRIADENT GmbH XiVE® Dental Implant KO013867 03/15/2002 System FRIADENT GmbH XiVE® Dental Implant K021318 08/02/2002 Implant System 313 FRIADENT GmbH XiW@Dental Implant System Special Remarket 51O(k) Notificathn 17.4… | 2002 |
What descends from it? (542)
See all 5426 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?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
- 2 of the 15 ancestors have a recall of any class.
- Of its descendants, K033984 (Institut Straumann AG, 2004) has gone furthest, with 376 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 (≥ 9.5mm 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K032158 · printed Nov 3, 2026
Cite this page
510(k) Report. “K032158: Xive Dental Implant System Multiple.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K032158
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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