510(k) · Cleared
ClearedXive Transgingival 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 3, 2003 as substantially equivalent to K013067 (Friadent GmbH, 2002) and 1 other predicate after an 89-day review. Its family tree reaches back 4 generations to 1990. 425 later devices descend from it.
- Decided
- Mar 3, 2003
- Review
- 89 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. 425 later devices descend from it, 5 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 deviceK024004 Xive Transgingival Dental Implant SystemFriadent GmbH · 2003
- Descendant · cites it directly · 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
- Descendant · 3 generations on · 295 of its ownK053088 Slactive ImplantsInstitut Straumann AG · 2006
- Descendant · 4 generations on · 228 of its ownK083550 Straumann Dental Implant SystemStraumann USA · 2009
- Descendant · 4 generations on · 228 of its ownK060958 Straumann Narrow Neck ImplantsStraumann USA · 2006
Showing 5 of 425 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 425 · See all- K032284Xive TG Dental Implant SystemFriadent GmbH · 2003 · cites it directly394descendants
- K033984Straumann Dental Implant SystemInstitut Straumann AG · 2004 · 2 generations on376descendants
- K053088Slactive ImplantsInstitut Straumann AG · 2006 · 3 generations on295descendants
- K083550Straumann Dental Implant SystemStraumann USA · 2009 · 4 generations on228descendants
- K060958Straumann Narrow Neck ImplantsStraumann USA · 2006 · 4 generations on228descendants
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) | K024004 | Xive Transgingival Dental Implant System | Friadent GmbH | 2003 | — |
| +1 | K032284 | Xive TG Dental Implant System | Friadent GmbH | 2003 | — |
| +2 | K033984 | Straumann Dental Implant System | Institut Straumann AG | 2004 | — |
| +3 | K053088 | Slactive Implants | Institut Straumann AG | 2006 | — |
| +4 | K083550 | Straumann Dental Implant System | Straumann USA | 2009 | — |
| +4 | K060958 | Straumann Narrow Neck Implants | Straumann USA | 2006 | — |
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 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 5 | 0 |
| 2008 | 6 | 0 |
| 2009 | 3 | 0 |
| 2010 | 8 | 0 |
| 2011 | 10 | 0 |
| 2012 | 14 | 0 |
| 2013 | 20 | 0 |
| 2014 | 16 | 0 |
| 2015 | 22 | 0 |
| 2016 | 18 | 0 |
| 2017 | 20 | 0 |
| 2018 | 26 | 0 |
| 2019 | 19 | 0 |
| 2020 | 29 | 0 |
| 2021 | 30 | 0 |
| 2022 | 31 | 0 |
| 2023 | 41 | 0 |
| 2024 | 43 | 0 |
| 2025 | 32 | 0 |
| 2026 | 21 | 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? (425)
See all 4255 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 2.1 years on median.
- 2 of the 14 ancestors have a recall of any class.
- Of its descendants, K032284 (Friadent GmbH, 2003) has gone furthest, with 394 descendants of its own.
- 1 other device also cites its predicate K013067.
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@Transgingival Dental Implant System is indicated for single-stage implant placement, with a minimum healing phase of three months in good quality bone and four months in spongy bone, for maxillary and mandibular splinted crowns, bridges and bar-retained overdenture restorations. The bridge must be supported by a minimum of two transgingival threaded implants. In the edentulous maxilla, a minimum of four transgingival implants are placed in a…
Read the full statement (106 words)
The XiVE@Transgingival Dental Implant System is indicated for single-stage implant placement, with a minimum healing phase of three months in good quality bone and four months in spongy bone, for maxillary and mandibular splinted crowns, bridges and bar-retained overdenture restorations. The bridge must be supported by a minimum of two transgingival threaded implants.
In the edentulous maxilla, a minimum of four transgingival implants are placed in a trapezoidal distribution and rigidly splinted together.
In the edentulous mandible, a minimum of four transgingival implants 2 9.5mm 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/K024004 · printed Nov 3, 2026
Cite this page
510(k) Report. “K024004: Xive Transgingival Dental Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K024004
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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