510(k) · Cleared
ClearedDental Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hager& Meisinger GmbH · DZE Implant, Endosseous, Root-Form
Cleared on Jun 13, 2014 after a 652-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it.
- Decided
- Jun 13, 2014
- Review
- 652 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 2 citing it directly.
- This deviceK122807 Dental Implant SystemHager& Meisinger GmbH · 2014
- Descendant · cites it directly · 8 of its ownK143539 Dental Implant OKTAGON Bone LevelHager& Meisinger GmbH · 2015
- Descendant · 2 generations on · 3 of its ownK173819 MyPlant II Implant SystemHager& Meisinger GmbH · 2018
- Descendant · 3 generations on · 2 of its ownK183024 Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda · 2020
- Descendant · 2 generations on · 1 of its ownK170287 Dental Implants OKTAGON Bone Level Tapered DesignHager& Meisinger GmbH · 2017
- Descendant · 4 generations on · 0 of its ownK202832 Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda · 2021
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K143539Dental Implant OKTAGON Bone LevelHager& Meisinger GmbH · 2015 · cites it directly8descendants
- K173819MyPlant II Implant SystemHager& Meisinger GmbH · 2018 · 2 generations on3descendants
- K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda · 2020 · 3 generations on2descendants
- K170287Dental Implants OKTAGON Bone Level Tapered DesignHager& Meisinger GmbH · 2017 · 2 generations on1descendant
- K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda · 2021 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K122807 | Dental Implant System | Hager& Meisinger GmbH | 2014 | — |
| +1 | K143539 | Dental Implant OKTAGON Bone Level | Hager& Meisinger GmbH | 2015 | — |
| +2 | K173819 | MyPlant II Implant System | Hager& Meisinger GmbH | 2018 | — |
| +3 | K183024 | Implacil Implant System | Implacil DE Bortoli Material Odontologico Ltda | 2020 | — |
| +2 | K170287 | Dental Implants OKTAGON Bone Level Tapered Design | Hager& Meisinger GmbH | 2017 | — |
| +4 | K202832 | Implacil Implant System | Implacil DE Bortoli Material Odontologico Ltda | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 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 has not posted a summary or statement for it, so its predicates are not known.
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?
- Of its descendants, K143539 (Hager& Meisinger GmbH, 2015) has gone furthest, with 8 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. 2014, 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 | — |
https://510kreport.com/device/K122807 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122807: Dental Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122807
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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