510(k) · Cleared
ClearedKlockner Dental Implant Abutments (II)
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 Jan 29, 2016 as substantially equivalent to K122988 (Soadco, S.L., 2013) after a 270-day review. Its family tree reaches back 9 generations to 1990. 4 later devices descend from it.
- Decided
- Jan 29, 2016
- Review
- 270 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K894595 (1990). 122 ancestors in all, the oldest K820013 (1982). 4 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 5 generations between
- 3 generations backK040170 Friadent Plus Dental Implant SystemsFriadent GmbH · 2004
- 2 generations backK102804 Spi Titanium Base for Cad/CamThommen Medical AG · 2011
- 1 generation backK122988 Klockner Dental Implant AbutmentsSoadco, S.L. · 2013
- This deviceK151194 Klockner Dental Implant Abutments (II)Soadco, S.L. · 2016
- Descendant · cites it directly · 2 of its ownK160850 Nucleoss Tpure Implant SystemSanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti · 2017
- Descendant · 2 generations on · 0 of its ownK231100 Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing…Proimtech Saglik Urunleri Anonim Sirketi · 2024
- Descendant · cites it directly · 0 of its ownK230103 Klockner AbutmentsSoadco, S.L. · 2023
- Descendant · 2 generations on · 0 of its ownK192062 Nucleoss T6 Dental Implant SystemSanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST · 2020
Show all 9 generations
- Root · 9 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 8 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 7 generations backK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
- 6 generations backK013067 Frialoc Dental Implant SystemFriadent GmbH · 2002
- 5 generations backK021318 Xive Dental Implant SystemFriadent GmbH · 2002
- 4 generations backK032158 Xive Dental Implant System MultipleFriadent GmbH · 2003
- 3 generations backK040170 Friadent Plus Dental Implant SystemsFriadent GmbH · 2004
- 2 generations backK102804 Spi Titanium Base for Cad/CamThommen Medical AG · 2011
- 1 generation backK122988 Klockner Dental Implant AbutmentsSoadco, S.L. · 2013
- This deviceK151194 Klockner Dental Implant Abutments (II)Soadco, S.L. · 2016
Most influential descendants
Showing 4 of 4 · See all- K160850Nucleoss Tpure Implant SystemSanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti · 2017 · cites it directly2descendants
- K231100Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech…Proimtech Saglik Urunleri Anonim Sirketi · 2024 · 2 generations on0descendants
- K230103Klockner AbutmentsSoadco, S.L. · 2023 · cites it directly0descendants
- K192062Nucleoss T6 Dental Implant SystemSanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −8 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −7 | K992937 | Dental Implant | Nobel Biocare Uas, Inc. | 2000 | 1 |
| −6 | K013067 | Frialoc Dental Implant System | Friadent GmbH | 2002 | — |
| −5 | K021318 | Xive Dental Implant System | Friadent GmbH | 2002 | — |
| −4 | K032158 | Xive Dental Implant System Multiple | Friadent GmbH | 2003 | — |
| −3 | K040170 | Friadent Plus Dental Implant Systems | Friadent GmbH | 2004 | — |
| −2 | K102804 | Spi Titanium Base for Cad/Cam | Thommen Medical AG | 2011 | — |
| −1 | K122988 | Klockner Dental Implant Abutments | Soadco, S.L. | 2013 | — |
| 0 (this device) | K151194 | Klockner Dental Implant Abutments (II) | Soadco, S.L. | 2016 | — |
| +1 | K160850 | Nucleoss Tpure Implant System | Sanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti | 2017 | — |
| +2 | K231100 | Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap… | Proimtech Saglik Urunleri Anonim Sirketi | 2024 | — |
| +1 | K230103 | Klockner Abutments | Soadco, S.L. | 2023 | — |
| +2 | K192062 | Nucleoss T6 Dental Implant System | Sanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST | 2020 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 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 |
|---|---|---|---|
| * | K122988 | Klockner Dental Implant AbutmentsSummary page 4…y Marketed (Predicate) Device: PREDICATE DEVICE Device Trade Name Manufacturer 510(k) Number K122988 Klockner Dental Implant Abutments SOADCO S.L. Device Description: Klockner Dental Implant Abutm… | 2013 |
| † | K080224 | Klockner Essential Dental Implants System, Models Essential Cone (EC), Essential Solid… | 2008 |
| † | K121843 | NP-Cast Abutment System | 2012 |
What descends from it? (4)
2 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 26 years and passes through 6 companies; a new generation was cleared every 2.1 years on median.
- 14 of the 122 ancestors have a recall of any class.
- Of its descendants, K160850 (Sanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti, 2017) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K122988.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
The Klockner Dental Implant Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges. The Klockner Dental Implant Abutments include protective cap, temporary abutment, angled abutments, straight abutments, cast abutments. All abutments are intended to be used with the Klockner Dental Implant Systems, models: Essential EC, Essential EC 1.5.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151194 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151194: Klockner Dental Implant Abutments (II).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151194
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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