510(k) · Cleared
ClearedKlockner Abutments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Soadco, S.L. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Apr 24, 2023 as substantially equivalent to K151194 (Soadco, S.L., 2016) after a 101-day review. Its family tree reaches back 10 generations to 1990.
- Decided
- Apr 24, 2023
- Review
- 101 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K894595 (1990). 123 ancestors in all, the oldest K820013 (1982). No later device cites it as a predicate yet.
- Root · 10 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 6 generations between
- 3 generations backK102804 Spi Titanium Base for Cad/CamThommen Medical AG · 2011
- 2 generations backK122988 Klockner Dental Implant AbutmentsSoadco, S.L. · 2013
- 1 generation backK151194 Klockner Dental Implant Abutments (II)Soadco, S.L. · 2016
- This deviceK230103 Klockner AbutmentsSoadco, S.L. · 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 backK040170 Friadent Plus Dental Implant SystemsFriadent GmbH · 2004
- 3 generations backK102804 Spi Titanium Base for Cad/CamThommen Medical AG · 2011
- 2 generations backK122988 Klockner Dental Implant AbutmentsSoadco, S.L. · 2013
- 1 generation backK151194 Klockner Dental Implant Abutments (II)Soadco, S.L. · 2016
- This deviceK230103 Klockner AbutmentsSoadco, S.L. · 2023
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 | K040170 | Friadent Plus Dental Implant Systems | Friadent GmbH | 2004 | — |
| −3 | K102804 | Spi Titanium Base for Cad/Cam | Thommen Medical AG | 2011 | — |
| −2 | K122988 | Klockner Dental Implant Abutments | Soadco, S.L. | 2013 | — |
| −1 | K151194 | Klockner Dental Implant Abutments (II) | Soadco, S.L. | 2016 | — |
| 0 (this device) | K230103 | Klockner Abutments | Soadco, S.L. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1987 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 1 | 0 |
| 1993 | 12 | 0 |
| 1994 | 11 | 0 |
| 1995 | 6 | 0 |
| 1996 | 9 | 0 |
| 1997 | 5 | 0 |
| 1998 | 4 | 0 |
| 1999 | 5 | 0 |
| 2000 | 2 | 0 |
| 2001 | 6 | 0 |
| 2002 | 10 | 0 |
| 2003 | 8 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 5 | 0 |
| 2007 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 4 | 0 |
| 2010 | 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? (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 |
|---|---|---|---|
| * | K151194 | Klockner Dental Implant Abutments (II)Summary page 4…Product Code NHA Classification Panel Dental Products Panel Reviewing Branch Dental Devices Branch PREDICATE DEVICE INFORMATION Primary Predicate Device K151194, Klockner Dental Implant Abutments (II), SOADCO, S.L. Reference Devices K170022, Klockner Vega TiBase for CEREC®, SOADCO, S.L. K… | 2016 |
| † | K170022 | Klockner Vega TiBase for CEREC | 2017 |
| † | K222288 | DESS Dental Smart Solutions | 2022 |
| † | K191123 | Multi-unit Abutments | 2020 |
| † | K220612 | PrimeLOC Attachment System | 2022 |
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 33 years and passes through 6 companies; a new generation was cleared every 2.2 years on median.
- 14 of the 123 ancestors have a recall of any class.
- 1 other device also cites its predicate K151194.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
Klockner Abutments are intended for use in dental implants to provide a support structure so that the edentulous or partially edentulous patients will regain their masticatory and aesthetic functions.
All digitally designed abutments for use with Klockner TiBase Abutments are intended to be sent to a SOADCO S.L. validated milling center for manufacture.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230103 · printed Nov 5, 2026
Cite this page
510(k) Report. “K230103: Klockner Abutments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K230103
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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