510(k) · Cleared
ClearedDental Implants OKTAGON Tissue Level and 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 Feb 24, 2017 as substantially equivalent to K122807 (Hager& Meisinger GmbH, 2014) and 1 other predicate after a 212-day review. Its family tree reaches back 9 generations to 1990.
- Decided
- Feb 24, 2017
- Review
- 212 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K894844 (1990). 23 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK162073 Dental Implants OKTAGON Tissue Level and Bone LevelHager& Meisinger GmbH · 2017
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 deviceK162073 Dental Implants OKTAGON Tissue Level and Bone LevelHager& Meisinger GmbH · 2017
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) | K162073 | Dental Implants OKTAGON Tissue Level and Bone Level | Hager& Meisinger GmbH | 2017 | — |
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 |
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 |
|---|---|---|---|
| * | K122807 | Dental Implant SystemSummary page 4…II Panel: Dental 4. Predicate Devices 510(k) No. Manufacturer Trade Name K122807 Hager & Meisinger GmbH Dental Implant OKTAGON® (Primary Predicate Device) K143539… | 2014 |
| * | K143539 | Dental Implant OKTAGON Bone LevelSummary page 4…Manufacturer Trade Name K122807 Hager & Meisinger GmbH Dental Implant OKTAGON® (Primary Predicate Device) K143539 Hager & Meisinger GmbH Dental Implant System (Reference Predicate Device)… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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 27 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- 1 of the 23 ancestors has a recall of any class.
- 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. 2017, 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 parts are intended to be used with OKTAGON® respectively Bone Level abutments and prosthetic parts.
The OKTAGON Implant 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/K162073 · printed Nov 5, 2026
Cite this page
510(k) Report. “K162073: Dental Implants OKTAGON Tissue Level and Bone Level.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K162073
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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