510(k) · Cleared
ClearedKlockner Dental Implants, Models SK, NK, IK, S3, and S4
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Soadco, S.L. · DZE Implant, Endosseous, Root-Form
Cleared on Jun 4, 2002 after a 504-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 12 later devices descend from it.
- Decided
- Jun 4, 2002
- Review
- 504 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 2 citing it directly.
- This deviceK010132 Klockner Dental Implants, Models SK, NK, IK, S3, and S4Soadco, S.L. · 2002
- Descendant · cites it directly · 11 of its ownK080224 Klockner Essential Dental Implants System, Models Essential Cone…Soadco, S.L. · 2008
- Descendant · 2 generations on · 10 of its ownK082200 Klockner Essential Dental Implants System, Model Essential Cone 1.5Soadco, S.L. · 2008
- Descendant · cites it directly · 9 of its ownK122988 Klockner Dental Implant AbutmentsSoadco, S.L. · 2013
- Descendant · 2 generations on · 4 of its ownK151194 Klockner Dental Implant Abutments (II)Soadco, S.L. · 2016
- Descendant · 2 generations on · 3 of its ownK160221 Implance Dental Implant System, Implance Dental Abutment SystemAgs Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti. · 2016
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K080224Klockner Essential Dental Implants System, Models Essential Cone (EC), Essential Solid…Soadco, S.L. · 2008 · cites it directly11descendants
- K082200Klockner Essential Dental Implants System, Model Essential Cone 1.5Soadco, S.L. · 2008 · 2 generations on10descendants
- K122988Klockner Dental Implant AbutmentsSoadco, S.L. · 2013 · cites it directly9descendants
- K151194Klockner Dental Implant Abutments (II)Soadco, S.L. · 2016 · 2 generations on4descendants
- K160221Implance Dental Implant System, Implance Dental Abutment SystemAgs Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti. · 2016 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010132 | Klockner Dental Implants, Models SK, NK, IK, S3, and S4 | Soadco, S.L. | 2002 | — |
| +1 | K080224 | Klockner Essential Dental Implants System, Models Essential Cone (EC)… | Soadco, S.L. | 2008 | — |
| +2 | K082200 | Klockner Essential Dental Implants System, Model Essential Cone 1.5 | Soadco, S.L. | 2008 | — |
| +1 | K122988 | Klockner Dental Implant Abutments | Soadco, S.L. | 2013 | — |
| +2 | K151194 | Klockner Dental Implant Abutments (II) | Soadco, S.L. | 2016 | — |
| +2 | K160221 | Implance Dental Implant System, Implance Dental Abutment System | Ags Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2013 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (12)
See all 122 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?
- Of its descendants, K080224 (Soadco, S.L., 2008) has gone furthest, with 11 descendants of its own.
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 | — |
https://510kreport.com/device/K010132 · printed Nov 6, 2026
Cite this page
510(k) Report. “K010132: Klockner Dental Implants, Models SK, NK, IK, S3, and S4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010132
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026