510(k) · Cleared
ClearedDental Implant OKTAGON Bone Level
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 31, 2015 as substantially equivalent to K122807 (Hager& Meisinger GmbH, 2014) and 4 other predicates after a 259-day review. Its family tree reaches back 8 generations to 1990. 8 later devices descend from it.
- Decided
- Aug 31, 2015
- Review
- 259 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 8 generations to K894844 (1990). 22 ancestors in all. 8 later devices descend from it, 5 citing it directly.
- Root · 8 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 7 generations backK990342 Synocta ProstheticsStraumann USA · 1999
- 6 generations backK013798 Prosthetic Accessories to the Iti Dental Implant SystemInstitut Straumann AG · 2001
- 5 generations backK020096 Esthetic Ease Abutments for the Iti Dental Implant SystemInstitut Straumann AG · 2002 · Recalled
- 4 generations backK033243 Iti Synocta Meso AbutmentsStraumann USA · 2003
- 3 generations backK062129 P.0004 ImplantsInstitut Straumann AG · 2006
- 2 generations backK072071 Straumann P.004 Cementable Abutments, Temporary Copings and…Institut Straumann AG · 2007
- 1 generation backK080286 Cementable Abuntments; Temporary Copings; Protective CapsStraumann USA · 2008
- This deviceK143539 Dental Implant OKTAGON Bone LevelHager& Meisinger GmbH · 2015
- Descendant · cites it directly · 3 of its ownK173819 MyPlant II Implant SystemHager& Meisinger GmbH · 2018
- Descendant · 2 generations on · 2 of its ownK183024 Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda · 2020
- Descendant · cites it directly · 1 of its ownK170287 Dental Implants OKTAGON Bone Level Tapered DesignHager& Meisinger GmbH · 2017
- Descendant · 3 generations on · 0 of its ownK202832 Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda · 2021
- Descendant · 3 generations on · 0 of its ownK192839 DSP Implant SystemD.S.P Industrial Eireli · 2021
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K173819MyPlant II Implant SystemHager& Meisinger GmbH · 2018 · cites it directly3descendants
- K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda · 2020 · 2 generations on2descendants
- K170287Dental Implants OKTAGON Bone Level Tapered DesignHager& Meisinger GmbH · 2017 · cites it directly1descendant
- K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda · 2021 · 3 generations on0descendants
- K192839DSP Implant SystemD.S.P Industrial Eireli · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −7 | K990342 | Synocta Prosthetics | Straumann USA | 1999 | — |
| −6 | K013798 | Prosthetic Accessories to the Iti Dental Implant System | Institut Straumann AG | 2001 | — |
| −5 | K020096 | Esthetic Ease Abutments for the Iti Dental Implant System | Institut Straumann AG | 2002 | 1 |
| −4 | K033243 | Iti Synocta Meso Abutments | Straumann USA | 2003 | — |
| −3 | K062129 | P.0004 Implants | Institut Straumann AG | 2006 | — |
| −2 | K072071 | Straumann P.004 Cementable Abutments, Temporary Copings and Protective Caps | Institut Straumann AG | 2007 | — |
| −1 | K080286 | Cementable Abuntments; Temporary Copings; Protective Caps | Straumann USA | 2008 | — |
| 0 (this device) | K143539 | Dental Implant OKTAGON Bone Level | Hager& Meisinger GmbH | 2015 | — |
| +1 | K173819 | MyPlant II Implant System | Hager& Meisinger GmbH | 2018 | — |
| +2 | K183024 | Implacil Implant System | Implacil DE Bortoli Material Odontologico Ltda | 2020 | — |
| +1 | K170287 | Dental Implants OKTAGON Bone Level Tapered Design | Hager& Meisinger GmbH | 2017 | — |
| +3 | K202832 | Implacil Implant System | Implacil DE Bortoli Material Odontologico Ltda | 2021 | — |
| +3 | 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 |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 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? (5)
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 |
|---|---|---|---|
| * | K122807 | Dental Implant SystemSummary page 4…Panel: Dental 4. Predicate Devices: 510(k) No. Manufacturer Trade Name K122807 Meisinger Dental Implant OKTAGON K062129 Straumann P.004 Implant… | 2014 |
| * | K062129 | P.0004 ImplantsSummary page 4…510(k) No. Manufacturer Trade Name K122807 Meisinger Dental Implant OKTAGON K062129 Straumann P.004 Implant K132214 Meisinger Dental Abutment OKTAGO… | 2006 |
| * | K132214 | Abutment RP, Abutment WP, Burn-Out Coping, Screws, Titanium Adhesive Base, Alligator…Summary page 4…K122807 Meisinger Dental Implant OKTAGON K062129 Straumann P.004 Implant K132214 Meisinger Dental Abutment OKTAGON K072071 Straumann P.004 RC Cem… | 2014 |
| * | K072071 | Straumann P.004 Cementable Abutments, Temporary Copings and Protective CapsSummary page 4…K062129 Straumann P.004 Implant K132214 Meisinger Dental Abutment OKTAGON K072071 Straumann P.004 RC Cementable Abutments K080286 Straumann P.004… | 2007 |
| * | K080286 | Cementable Abuntments; Temporary Copings; Protective CapsSummary page 4…214 Meisinger Dental Abutment OKTAGON K072071 Straumann P.004 RC Cementable Abutments K080286 Straumann P.004 NC Cementable Abutments 5. Device Description: The Bone… | 2008 |
What descends from it? (8)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173819 | MyPlant II Implant System | 2018 | 3 |
| K170287 | Dental Implants OKTAGON Bone Level Tapered Design | 2017 | 1 |
| K180360 | OKTAGON Implant System | 2018 | 0 |
| K162073 | Dental Implants OKTAGON Tissue Level and Bone Level | 2017 | 0 |
| K160132 | Dental Implant Abutment OKTAGON Bone Level RC, Dental Implant Abutment OKTAGON Bone… | 2016 | 0 |
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 25 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 22 ancestors has a recall of any class.
- Of its descendants, K173819 (Hager& Meisinger GmbH, 2018) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K122807.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 implants are surgically placed in the maxillary and/ or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. The implants are intended to be used with OKTAGON® Bone Level abutments and prosthetic parts. Dental Implant Abutments Bone Level are intended to provide support for prosthetic reconstructions. Prosthetic applications can include individual crowns, bridges, partial or total…
Read the full statement (127 words)
The implants are surgically placed in the maxillary and/ or mandibular
arches to provide support for prosthetic restorations in edentulous or
partially edentulous patients. The implants are intended to be used with
OKTAGON® Bone Level abutments and prosthetic parts.
Dental Implant Abutments Bone Level are intended to provide support for
prosthetic reconstructions. Prosthetic applications can include individual
crowns, bridges, partial or total prostheses.
Abutments can be used in single tooth replacements and multiple tooth
restorations. The Abutments are intended to be compatible to OKTAGON®
Bone Level implants with diameters 3.3mm, 4.1mm and 4.8mm and with
the lengths 8mm, 10mm, 12mm and 14mm.
The Oktagon Bone Level System is intended for delayed loading, or for
immediate loading when good primary stability is achieved and with
appropriate occlusal load.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143539 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143539: Dental Implant OKTAGON Bone Level.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143539
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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