510(k) · Cleared
ClearedBiodenta Dental Implant System - Bone Level
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biodenta Swiss AG · DZE Implant, Endosseous, Root-Form
Cleared on Sep 15, 2011 as substantially equivalent to K093630 (Biodenta Swiss AG, 2010) and 1 other predicate after a 157-day review. Its family tree reaches back 10 generations to 1990. 17 later devices descend from it.
- Decided
- Sep 15, 2011
- Review
- 157 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K894595 (1990). 50 ancestors in all, the oldest K894844 (1990). 17 later devices descend from it, 4 citing it directly.
- Root · 10 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 6 generations between
- 3 generations backK053088 Slactive ImplantsInstitut Straumann AG · 2006
- 2 generations backK081419 Straumann Dental Implant SystemInstitut Straumann AG · 2009
- 1 generation backK093630 Biodenta Dental Implant SystemBiodenta Swiss AG · 2010
- This deviceK111003 Biodenta Dental Implant System - Bone LevelBiodenta Swiss AG · 2011
- Descendant · cites it directly · 11 of its ownK123491 Biodenta Dental Implant System - Multi-Use AbutmentBiodenta Swiss AG · 2013
- Descendant · 2 generations on · 8 of its ownK203252 Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc. · 2021
- Descendant · 3 generations on · 3 of its ownK213106 BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl. · 2022
- Descendant · 3 generations on · 2 of its ownK240187 Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc. · 2024
- Descendant · 4 generations on · 2 of its ownK231827 BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl. · 2023
Show all 10 generations
- Root · 10 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 9 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 8 generations backK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
- 7 generations backK013067 Frialoc Dental Implant SystemFriadent GmbH · 2002
- 6 generations backK021318 Xive Dental Implant SystemFriadent GmbH · 2002
- 5 generations backK032158 Xive Dental Implant System MultipleFriadent GmbH · 2003
- 4 generations backK033984 Straumann Dental Implant SystemInstitut Straumann AG · 2004
- 3 generations backK053088 Slactive ImplantsInstitut Straumann AG · 2006
- 2 generations backK081419 Straumann Dental Implant SystemInstitut Straumann AG · 2009
- 1 generation backK093630 Biodenta Dental Implant SystemBiodenta Swiss AG · 2010
- This deviceK111003 Biodenta Dental Implant System - Bone LevelBiodenta Swiss AG · 2011
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K123491Biodenta Dental Implant System - Multi-Use AbutmentBiodenta Swiss AG · 2013 · cites it directly11descendants
- K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc. · 2021 · 2 generations on8descendants
- K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl. · 2022 · 3 generations on3descendants
- K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc. · 2024 · 3 generations on2descendants
- K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl. · 2023 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −9 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −8 | K992937 | Dental Implant | Nobel Biocare Uas, Inc. | 2000 | 1 |
| −7 | K013067 | Frialoc Dental Implant System | Friadent GmbH | 2002 | — |
| −6 | K021318 | Xive Dental Implant System | Friadent GmbH | 2002 | — |
| −5 | K032158 | Xive Dental Implant System Multiple | Friadent GmbH | 2003 | — |
| −4 | K033984 | Straumann Dental Implant System | Institut Straumann AG | 2004 | — |
| −3 | K053088 | Slactive Implants | Institut Straumann AG | 2006 | — |
| −2 | K081419 | Straumann Dental Implant System | Institut Straumann AG | 2009 | — |
| −1 | K093630 | Biodenta Dental Implant System | Biodenta Swiss AG | 2010 | — |
| 0 (this device) | K111003 | Biodenta Dental Implant System - Bone Level | Biodenta Swiss AG | 2011 | — |
| +1 | K123491 | Biodenta Dental Implant System - Multi-Use Abutment | Biodenta Swiss AG | 2013 | — |
| +2 | K203252 | Multi-unit Abutments for CONELOG | BioHorizons Implant Systems, Inc. | 2021 | — |
| +3 | K213106 | BTI Interna Dental Implant System UnicCa - Prosthetic Components | B.T.I. Biotechnology Institute, Sl. | 2022 | — |
| +3 | K240187 | Tapered Pro Conical Implant System | BioHorizons Implant Systems, Inc. | 2024 | — |
| +4 | K231827 | BTI Dental Implant System UnicCa® – Aesthetic Post Abutments | B.T.I. Biotechnology Institute, Sl. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1993 | 3 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 6 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 4 | 0 |
| 2002 | 5 | 0 |
| 2003 | 4 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 4 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K093630 | Biodenta Dental Implant SystemSummary page 1…dicate device): Company: Biodenta Swiss AG Device name: Biodenta Dental Implant System 510(k) number: K093630 Company: Nobel Biocare Ab Device name: Nobelactive Internal Connection Implant 5… | 2010 |
| * | K071370 | Nobelactive Internal Connection ImplantSummary page 1…K093630 Company: Nobel Biocare Ab Device name: Nobelactive Internal Connection Implant 510(k) number: K071370 Revision 2.0… | 2007 |
What descends from it? (17)
See all 174 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?
- The line of descent spans 21 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 6 of the 50 ancestors have a recall of any class.
- Of its descendants, K123491 (Biodenta Swiss AG, 2013) has gone furthest, with 11 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. 2011, 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?
Biodenta bone level dental implants are intended for surgical placement in mandibles or maxillae to support single or multiple tooth restorations or terminal or intermediate abutment support for fixed or removable bridgework and to retain overdentures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111003 · printed Nov 5, 2026
Cite this page
510(k) Report. “K111003: Biodenta Dental Implant System - 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/K111003
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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