510(k) · Cleared
ClearedXive 3.0 Dental Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Friandent GmbH · DZE Implant, Endosseous, Root-Form
Cleared on Aug 12, 2003 as substantially equivalent to K994376 (Friadent GmbH, 2000) after a 165-day review. Its family tree reaches back 2 generations to 1993. 9 later devices descend from it.
- Decided
- Aug 12, 2003
- Review
- 165 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K925765 (1993). 9 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
- 1 generation backK994376 Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating…Friadent GmbH · 2000
- This deviceK030639 Xive 3.0 Dental Implant SystemFriandent GmbH · 2003
- Descendant · cites it directly · 7 of its ownK050970 Milo Dental Implant SystemIntra-Lock International · 2005
- Descendant · 2 generations on · 1 of its ownK131701 Z5MLB, Z5MLCZ-Systems AG · 2013
- Descendant · 2 generations on · 1 of its ownK130140 Intra-Lock OP Dental ImplantIntra-Lock International · 2013
- Descendant · 2 generations on · 1 of its ownK121707 Lew Mdi O-Ball Collared Implant,Park Dental Research Corp. · 2012
- Descendant · 3 generations on · 0 of its ownK200386 Z5-BLZ-Systems AG · 2020
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K050970Milo Dental Implant SystemIntra-Lock International · 2005 · cites it directly7descendants
- K131701Z5MLB, Z5MLCZ-Systems AG · 2013 · 2 generations on1descendant
- K130140Intra-Lock OP Dental ImplantIntra-Lock International · 2013 · 2 generations on1descendant
- K121707Lew Mdi O-Ball Collared Implant,Park Dental Research Corp. · 2012 · 2 generations on1descendant
- K200386Z5-BLZ-Systems AG · 2020 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K925765 | Branemark System Standard 3.75MM Fixture | Nobelpharma USA, Inc. | 1993 | — |
| −1 | K994376 | Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2… | Friadent GmbH | 2000 | — |
| 0 (this device) | K030639 | Xive 3.0 Dental Implant System | Friandent GmbH | 2003 | — |
| +1 | K050970 | Milo Dental Implant System | Intra-Lock International | 2005 | — |
| +2 | K131701 | Z5MLB, Z5MLC | Z-Systems AG | 2013 | — |
| +2 | K130140 | Intra-Lock OP Dental Implant | Intra-Lock International | 2013 | — |
| +2 | K121707 | Lew Mdi O-Ball Collared Implant, | Park Dental Research Corp. | 2012 | — |
| +3 | K200386 | Z5-BL | Z-Systems AG | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 1 | 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? (1)
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 |
|---|---|---|---|
| * | K994376 | Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2 3.4MM Steeped…Summary page 1…CATE DEVICES Companv Device 510(k) No, Date Cleared FRIADENT GmbH FRIALIT-2 3.4mm Dental K994376 03/24/2000 Implant with Deep Profile Surface 16.4… | 2000 |
What descends from it? (9)
2 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 10 years and passes through 3 companies; a new generation was cleared every 6.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K050970 (Intra-Lock International, 2005) has gone furthest, with 7 descendants of its own.
- 5 other devices also cite its predicate K994376.
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 3.0 Dental Implant System is indicated for single
tooth restorations and splinted tooth restorations in the
region of 7 to 10 and 23 to 26.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030639 · printed Nov 4, 2026
Cite this page
510(k) Report. “K030639: Xive 3.0 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/K030639
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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