510(k) · Cleared
ClearedKlockner Essential Dental Implants System, Model Essential Cone 1.5
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 Nov 25, 2008 as substantially equivalent to K080224 (Soadco, S.L., 2008) after a 113-day review. Its family tree reaches back 2 generations to 2002. 10 later devices descend from it.
- Decided
- Nov 25, 2008
- Review
- 113 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K010132 (2002). 3 ancestors in all. 10 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK010132 Klockner Dental Implants, Models SK, NK, IK, S3, and S4Soadco, S.L. · 2002
- 1 generation backK080224 Klockner Essential Dental Implants System, Models Essential Cone…Soadco, S.L. · 2008
- This deviceK082200 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
- Descendant · 3 generations on · 1 of its ownK181266 Implantswiss Dental Implant System, Implantswiss Dental Abutment…Novodent SA · 2018
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- 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
- K181266Implantswiss Dental Implant System, Implantswiss Dental Abutment SystemNovodent SA · 2018 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | 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 | — |
| +3 | K181266 | Implantswiss Dental Implant System, Implantswiss Dental Abutment System | Novodent SA | 2018 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K080224 | Klockner Essential Dental Implants System, Models Essential Cone (EC), Essential Solid…Summary page 2…872.3640) 3. PREDICATE DEVICE / LEGALLY MARKETED DEVICE NAME: Dental endosseous implant LEGALLYAMARKETED DEVICE: Klockner dental implants model Essential Cone (K080224) 4. DESCRIPTION The Klockner Essential Cone 1.5 implant system consists of a implants to restore the mastication… | 2008 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122988 | Klockner Dental Implant Abutments | 2013 | 9 |
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 6 years and passes through 1 company; a new generation was cleared every 6.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K122988 (Soadco, S.L., 2013) has gone furthest, with 9 descendants of its own.
- 1 other device also cites its predicate K080224.
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 to replace the root of the teeth, acting as the support for the dental implants formed by
implant accessories.
The Essential Cone 1.5 implants are fitted with an internal octagonal conical connection.
Immediate loading is appropriate for the Essential Cone 15 implants when good primary
stability is achieved with appropriate occlusal loading.
8mm Implants are not indicated for use as single implants and for immediate load.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082200 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082200: Klockner Essential Dental Implants System, Model Essential Cone 1.5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082200
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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