510(k) · Cleared
ClearedXive TG Abutments
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 Oct 2, 2003 as substantially equivalent to K024004 (Friadent GmbH, 2003) and 1 other predicate after a 69-day review. Its family tree reaches back 5 generations to 1990. 95 later devices descend from it.
- Decided
- Oct 2, 2003
- Review
- 69 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K894595 (1990). 19 ancestors in all, the oldest K894844 (1990). 95 later devices descend from it, 5 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 backK024004 Xive Transgingival Dental Implant SystemFriadent GmbH · 2003
- This deviceK032302 Xive TG AbutmentsFriadent GmbH · 2003
- Descendant · cites it directly · 84 of its ownK040170 Friadent Plus Dental Implant SystemsFriadent GmbH · 2004
- Descendant · 2 generations on · 83 of its ownK102804 Spi Titanium Base for Cad/CamThommen Medical AG · 2011
- Descendant · 3 generations on · 45 of its ownK103691 Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc. · 2011 · Recalled
- Descendant · 4 generations on · 36 of its ownK112440 AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd. · 2012
- Descendant · 3 generations on · 30 of its ownK103291 Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc. · 2011
Showing 5 of 95 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 95 · See all- K040170Friadent Plus Dental Implant SystemsFriadent GmbH · 2004 · cites it directly84descendants
- K102804Spi Titanium Base for Cad/CamThommen Medical AG · 2011 · 2 generations on83descendants
- K103691Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc. · 2011 · 3 generations on45descendants
- K112440AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd. · 2012 · 4 generations on36descendants
- K103291Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc. · 2011 · 3 generations on30descendants
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 | K024004 | Xive Transgingival Dental Implant System | Friadent GmbH | 2003 | — |
| 0 (this device) | K032302 | Xive TG Abutments | Friadent GmbH | 2003 | — |
| +1 | K040170 | Friadent Plus Dental Implant Systems | Friadent GmbH | 2004 | — |
| +2 | K102804 | Spi Titanium Base for Cad/Cam | Thommen Medical AG | 2011 | — |
| +3 | K103691 | Biohorizons Abutments for Zimmer | BioHorizons Implant Systems, Inc. | 2011 | 1 |
| +4 | K112440 | AB Dental Devices Implants and Accessories | A.B. Dental Devices, Ltd. | 2012 | — |
| +3 | K103291 | Biohorizons Laser-Lok Abutments for Nobel Biocare | BioHorizons Implant Systems, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 5 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 5 | 0 |
| 2015 | 4 | 0 |
| 2016 | 7 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 5 | 0 |
| 2020 | 8 | 0 |
| 2021 | 6 | 0 |
| 2022 | 9 | 0 |
| 2023 | 8 | 0 |
| 2024 | 9 | 0 |
| 2025 | 9 | 0 |
| 2026 | 5 | 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? (95)
See all 955 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 11 months on median.
- 2 of the 19 ancestors have a recall of any class.
- Of its descendants, K040170 (Friadent GmbH, 2004) has gone furthest, with 84 descendants of its own.
- 4 other devices also cite its predicate K024004.
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@TG Abutment is intended for use to fabricate screw-retained or cementable crowns and bridges.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032302 · printed Nov 3, 2026
Cite this page
510(k) Report. “K032302: Xive TG Abutments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K032302
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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