510(k) · Cleared
ClearedKlockner Essential Dental Implants System, Models Essential Cone (EC), Essential Solid (ES) and Eck
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 Jul 3, 2008 as substantially equivalent to K052654 (Soadco, S.L., 2006) and 1 other predicate after a 156-day review. Its family tree reaches back 1 generation to 2002. 11 later devices descend from it.
- Decided
- Jul 3, 2008
- Review
- 156 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K010132 (2002). 2 ancestors in all. 11 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK010132 Klockner Dental Implants, Models SK, NK, IK, S3, and S4Soadco, S.L. · 2002
- This deviceK080224 Klockner Essential Dental Implants System, Models Essential Cone…Soadco, S.L. · 2008
- Descendant · cites it directly · 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
- Descendant · 2 generations on · 2 of its ownK160850 Nucleoss Tpure Implant SystemSanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti · 2017
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K082200Klockner Essential Dental Implants System, Model Essential Cone 1.5Soadco, S.L. · 2008 · cites it directly10descendants
- 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
- K160850Nucleoss Tpure Implant SystemSanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti · 2017 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010132 | Klockner Dental Implants, Models SK, NK, IK, S3, and S4 | Soadco, S.L. | 2002 | — |
| 0 (this device) | K080224 | Klockner Essential Dental Implants System, Models Essential Cone (EC)… | Soadco, S.L. | 2008 | — |
| +1 | 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 | — |
| +2 | K160850 | Nucleoss Tpure Implant System | Sanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 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), 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 |
|---|---|---|---|
| * | K052654 | Klockner Dental Implant, Model S3MSummary page 2…(21 CFR 872.3630) 3. PREDICATE DEVICE / LEGALLY MARKETED DEVICE NAME: Dental endosseous implant LEGALLY MARKETED DEVICE: Klockner dental implants models S3M (K052654) SK2, NK2, S4, S6 (K010132) Straumann RN Dental implants (K033922) (K030007) (K07188) (K062129) (K041295) (K070549) (K9620… | 2006 |
| * | K010132 | Klockner Dental Implants, Models SK, NK, IK, S3, and S4Summary page 2…DICATE DEVICE / LEGALLY MARKETED DEVICE NAME: Dental endosseous implant LEGALLY MARKETED DEVICE: Klockner dental implants models S3M (K052654) SK2, NK2, S4, S6 (K010132) Straumann RN Dental implants (K033922) (K030007) (K07188) (K062129) (K041295) (K070549) (K962023) (K071585) (K994119) (K0… | 2002 |
What descends from it? (11)
See all 112 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K082200 (Soadco, S.L., 2008) has gone furthest, with 10 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. 2008, this device’s year, is highlighted.
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 Klockner Essential implant system is especially designed for surgical insertion into the bone using additional material to replace the root of the teeth, acting as the support for the dental implants formed by implant accessories. The Essential Solid implants are fitted with an internal octagonal conical connection combined with an external octagonal connection measuring 1.2 mm in height. The Essential Cone implants are fitted with an internal…
Read the full statement (141 words)
The Klockner Essential implant system is especially designed for surgical insertion into the bone using additional material to replace the root of the teeth, acting as the support for the dental implants formed by implant accessories.
The Essential Solid implants are fitted with an internal octagonal conical connection combined with an external octagonal connection measuring 1.2 mm in height.
The Essential Cone implants are fitted with an internal octagonal conical connection.
The Essential ECK implants are fitted with a larger internal octagonal conical connection than that of the Essential Cone implants.
Immediate loading is appropriate for the Essential Solid, Essential Cone and Essential ECK implants when good primary stability is achieved with appropriate occlusal loading.
Abutments can be used in single tooth replacements and multiple tooth restorations.
8mm Implants are not indicated for use as unitary implants and for immediate load.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080224 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080224: Klockner Essential Dental Implants System, Models Essential Cone (EC), Essential Solid (ES) and Eck.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080224
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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