510(k) · Cleared
ClearedBiodenta Dental Implant System - Abutments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biodenta Swiss AG · NHA Abutment, Implant, Dental, Endosseous
Cleared on May 3, 2013 as substantially equivalent to K111003 (Biodenta Swiss AG, 2011) and 3 other predicates after a 254-day review. Its family tree reaches back 11 generations to 1990.
- Decided
- May 3, 2013
- Review
- 254 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 11 generations to K894595 (1990). 69 ancestors in all, the oldest K894844 (1990). No later device cites it as a predicate yet.
- Root · 11 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 7 generations between
- 3 generations backK081419 Straumann Dental Implant SystemInstitut Straumann AG · 2009
- 2 generations backK093630 Biodenta Dental Implant SystemBiodenta Swiss AG · 2010
- 1 generation backK111003 Biodenta Dental Implant System - Bone LevelBiodenta Swiss AG · 2011
- This deviceK122559 Biodenta Dental Implant System - AbutmentsBiodenta Swiss AG · 2013
Show all 11 generations
- Root · 11 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 10 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 9 generations backK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
- 8 generations backK013067 Frialoc Dental Implant SystemFriadent GmbH · 2002
- 7 generations backK021318 Xive Dental Implant SystemFriadent GmbH · 2002
- 6 generations backK032158 Xive Dental Implant System MultipleFriadent GmbH · 2003
- 5 generations backK033984 Straumann Dental Implant SystemInstitut Straumann AG · 2004
- 4 generations backK053088 Slactive ImplantsInstitut Straumann AG · 2006
- 3 generations backK081419 Straumann Dental Implant SystemInstitut Straumann AG · 2009
- 2 generations backK093630 Biodenta Dental Implant SystemBiodenta Swiss AG · 2010
- 1 generation backK111003 Biodenta Dental Implant System - Bone LevelBiodenta Swiss AG · 2011
- This deviceK122559 Biodenta Dental Implant System - AbutmentsBiodenta Swiss AG · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −10 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −9 | K992937 | Dental Implant | Nobel Biocare Uas, Inc. | 2000 | 1 |
| −8 | K013067 | Frialoc Dental Implant System | Friadent GmbH | 2002 | — |
| −7 | K021318 | Xive Dental Implant System | Friadent GmbH | 2002 | — |
| −6 | K032158 | Xive Dental Implant System Multiple | Friadent GmbH | 2003 | — |
| −5 | K033984 | Straumann Dental Implant System | Institut Straumann AG | 2004 | — |
| −4 | K053088 | Slactive Implants | Institut Straumann AG | 2006 | — |
| −3 | K081419 | Straumann Dental Implant System | Institut Straumann AG | 2009 | — |
| −2 | K093630 | Biodenta Dental Implant System | Biodenta Swiss AG | 2010 | — |
| −1 | K111003 | Biodenta Dental Implant System - Bone Level | Biodenta Swiss AG | 2011 | — |
| 0 (this device) | K122559 | Biodenta Dental Implant System - Abutments | Biodenta Swiss AG | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 4 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 7 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 6 | 0 |
| 2002 | 6 | 0 |
| 2003 | 4 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 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 NHA? 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 NHA device
- #1 K222288 DESS Dental Smart Solutionsscore 30.6 · 19 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K111003 | Biodenta Dental Implant System - Bone LevelSummary page 1…device): 1. Company: Biodenta Swiss AG Device name: Biodenta Dental Implant System - Bone Level 510(k) number: K1 11003 2. Company: Biohorizons Implant Systems, Inc. Device name: Biohorizons Plastic Temporary… | 2011 |
| * | K053099 | Biohorizons Plastic Temporary AbutmentsSummary page 1…2. Company: Biohorizons Implant Systems, Inc. Device name: Biohorizons Plastic Temporary Abutments 510(k) number. K053099 Revision 3.0… | 2006 |
| * | K092377 | Plastic Temporary Abutments, Models: PT341S, PT344S, PT341A, PT344A, PT451S, PT454S…Summary page 2…i d n a 3. Company: Zimmer Dental Inc. Device name: Plastic Temporary Abutments 510(k) number: K092377 4. Company: Implant Direct LLC. Device name: Spectra System Dental Implants 2008 510… | 2009 |
| * | K090234 | Spectra System Dental Implants 2008Summary page 2…K092377 4. Company: Implant Direct LLC. Device name: Spectra System Dental Implants 2008 510(k) number: K090234 Indications for Use: Biodenta Dental Implant System Abutments are intended for terminal or intermediate abutment support for f… | 2009 |
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 23 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 9 of the 69 ancestors have a recall of any class.
- 3 other devices also cite its predicate K111003.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · NHA
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NHA
147in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NHA
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NHA
838in 2025
MAUDE reports naming product code NHA, 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 | 38 | 91 | 1 | 1 |
| 2008 | 31 | 90 | 2 | 8 |
| 2009 | 30 | 95 | 0 | 30 |
| 2010 | 19 | 162 | 0 | 61 |
| 2011 | 31 | 130 | 5 | 56 |
| 2012 | 25 | 171 | 1 | 5 |
| 2013 | 22 | 184 | 1 | 143 |
| 2014 | 27 | 160 | 0 | 146 |
| 2015 | 29 | 151 | 1 | 858 |
| 2016 | 38 | 202 | 36 | 314 |
| 2017 | 31 | 188 | 2 | 577 |
| 2018 | 31 | 200 | 1 | 591 |
| 2019 | 28 | 160 | 0 | 530 |
| 2020 | 38 | 153 | 7 | 458 |
| 2021 | 29 | 211 | 0 | 546 |
| 2022 | 33 | 142 | 0 | 497 |
| 2023 | 51 | 147 | 3 | 618 |
| 2024 | 43 | 158 | 0 | 635 |
| 2025 | 40 | 147 | 1 | 838 |
| 2026 | 23 | 169 | 3 | — |
What is it indicated for?
Biodenta Dental Implant System Abutments are Intended for terminal or intermediate
abutment support for fixed or removable crown or bridgework.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122559 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122559: Biodenta Dental Implant System - Abutments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122559
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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