510(k) · Cleared
ClearedMyPlant II 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 Aug 9, 2018 as substantially equivalent to K143539 (Hager& Meisinger GmbH, 2015) after a 234-day review. Its family tree reaches back 9 generations to 1990. 3 later devices descend from it.
- Decided
- Aug 9, 2018
- Review
- 234 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K894844 (1990). 23 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 5 generations between
- 3 generations backK072071 Straumann P.004 Cementable Abutments, Temporary Copings and…Institut Straumann AG · 2007
- 2 generations backK080286 Cementable Abuntments; Temporary Copings; Protective CapsStraumann USA · 2008
- 1 generation backK143539 Dental Implant OKTAGON Bone LevelHager& Meisinger GmbH · 2015
- This deviceK173819 MyPlant II Implant SystemHager& Meisinger GmbH · 2018
- Descendant · cites it directly · 2 of its ownK183024 Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda · 2020
- Descendant · 2 generations on · 0 of its ownK202832 Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda · 2021
- Descendant · 2 generations on · 0 of its ownK192839 DSP Implant SystemD.S.P Industrial Eireli · 2021
Show all 9 generations
- Root · 9 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 8 generations backK990342 Synocta ProstheticsStraumann USA · 1999
- 7 generations backK013798 Prosthetic Accessories to the Iti Dental Implant SystemInstitut Straumann AG · 2001
- 6 generations backK020096 Esthetic Ease Abutments for the Iti Dental Implant SystemInstitut Straumann AG · 2002 · Recalled
- 5 generations backK033243 Iti Synocta Meso AbutmentsStraumann USA · 2003
- 4 generations backK062129 P.0004 ImplantsInstitut Straumann AG · 2006
- 3 generations backK072071 Straumann P.004 Cementable Abutments, Temporary Copings and…Institut Straumann AG · 2007
- 2 generations backK080286 Cementable Abuntments; Temporary Copings; Protective CapsStraumann USA · 2008
- 1 generation backK143539 Dental Implant OKTAGON Bone LevelHager& Meisinger GmbH · 2015
- This deviceK173819 MyPlant II Implant SystemHager& Meisinger GmbH · 2018
Most influential descendants
Showing 3 of 3 · See all- K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda · 2020 · cites it directly2descendants
- K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda · 2021 · 2 generations on0descendants
- K192839DSP Implant SystemD.S.P Industrial Eireli · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −8 | K990342 | Synocta Prosthetics | Straumann USA | 1999 | — |
| −7 | K013798 | Prosthetic Accessories to the Iti Dental Implant System | Institut Straumann AG | 2001 | — |
| −6 | K020096 | Esthetic Ease Abutments for the Iti Dental Implant System | Institut Straumann AG | 2002 | 1 |
| −5 | K033243 | Iti Synocta Meso Abutments | Straumann USA | 2003 | — |
| −4 | K062129 | P.0004 Implants | Institut Straumann AG | 2006 | — |
| −3 | K072071 | Straumann P.004 Cementable Abutments, Temporary Copings and Protective Caps | Institut Straumann AG | 2007 | — |
| −2 | K080286 | Cementable Abuntments; Temporary Copings; Protective Caps | Straumann USA | 2008 | — |
| −1 | K143539 | Dental Implant OKTAGON Bone Level | Hager& Meisinger GmbH | 2015 | — |
| 0 (this device) | K173819 | MyPlant II Implant System | Hager& Meisinger GmbH | 2018 | — |
| +1 | K183024 | Implacil Implant System | Implacil DE Bortoli Material Odontologico Ltda | 2020 | — |
| +2 | K202832 | Implacil Implant System | Implacil DE Bortoli Material Odontologico Ltda | 2021 | — |
| +2 | K192839 | DSP Implant System | D.S.P Industrial Eireli | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2014 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 2 | 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 |
|---|---|---|---|
| * | K143539 | Dental Implant OKTAGON Bone LevelSummary page 4…II Panel: Dental 4. Primary Predicate Device: 510(k) No. Manufacturer Trade Name K143539 Hager & Meisinger GmbH. Dental Implant System OKTAGON® Bone Level Reference Devices: 510(k) No. Manuf… | 2015 |
| † | K083805 | Ankylos C/X Dental Implant System | 2009 |
| † | K132214 | Abutment RP, Abutment WP, Burn-Out Coping, Screws, Titanium Adhesive Base, Alligator… | 2014 |
| † | K172505 | MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical… | 2017 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K183024 | Implacil Implant System | 2020 | 2 |
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 28 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 23 ancestors has a recall of any class.
- Of its descendants, K183024 (Implacil DE Bortoli Material Odontologico Ltda, 2020) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K143539.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 MyPlant II implants are surgically placed in the maxilla or mandible to enable prosthetic restorations in edentulous or partially edentulous patients. The implants are to be used exclusively with MyPlant II abutments and prosthetic components. The abutments serve for prosthetic restorations and can include individual Crowns, bridges, partial or full prostheses. Abutments can be used for single tooth restorations or for the restoration of several teeth. The implants are intended for delayed loading with two surgical interventions. In case of appropriate primary stability (35 Nem), immediate temporary restoration with appropriate occlusal load can also be performed.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K173819 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173819: MyPlant II 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/K173819
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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