510(k) · Cleared
ClearedKlockner Dental Implant 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 Jul 19, 2013 as substantially equivalent to K080224 (Soadco, S.L., 2008) and 15 other predicates after a 296-day review. Its family tree reaches back 8 generations to 1990. 9 later devices descend from it.
- Decided
- Jul 19, 2013
- Review
- 296 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 16
Its longest line of descent runs back 8 generations to K894595 (1990). 121 ancestors in all, the oldest K820013 (1982). 9 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 7 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 6 generations backK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
- 5 generations backK013067 Frialoc Dental Implant SystemFriadent GmbH · 2002
- 4 generations backK021318 Xive Dental Implant SystemFriadent GmbH · 2002
- 3 generations backK032158 Xive Dental Implant System MultipleFriadent GmbH · 2003
- 2 generations backK040170 Friadent Plus Dental Implant SystemsFriadent GmbH · 2004
- 1 generation backK102804 Spi Titanium Base for Cad/CamThommen Medical AG · 2011
- This deviceK122988 Klockner Dental Implant AbutmentsSoadco, S.L. · 2013
- Descendant · cites it directly · 4 of its ownK151194 Klockner Dental Implant Abutments (II)Soadco, S.L. · 2016
- Descendant · cites it directly · 3 of its ownK160221 Implance Dental Implant System, Implance Dental Abutment SystemAgs Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti. · 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 · 1 of its ownK181266 Implantswiss Dental Implant System, Implantswiss Dental Abutment…Novodent SA · 2018
- Descendant · 2 generations on · 0 of its ownK231100 Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing…Proimtech Saglik Urunleri Anonim Sirketi · 2024
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K151194Klockner Dental Implant Abutments (II)Soadco, S.L. · 2016 · cites it directly4descendants
- K160221Implance Dental Implant System, Implance Dental Abutment SystemAgs Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti. · 2016 · cites it directly3descendants
- K160850Nucleoss Tpure Implant SystemSanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti · 2017 · cites it directly2descendants
- K181266Implantswiss Dental Implant System, Implantswiss Dental Abutment SystemNovodent SA · 2018 · 2 generations on1descendant
- K231100Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech…Proimtech Saglik Urunleri Anonim Sirketi · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −7 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −6 | K992937 | Dental Implant | Nobel Biocare Uas, Inc. | 2000 | 1 |
| −5 | K013067 | Frialoc Dental Implant System | Friadent GmbH | 2002 | — |
| −4 | K021318 | Xive Dental Implant System | Friadent GmbH | 2002 | — |
| −3 | K032158 | Xive Dental Implant System Multiple | Friadent GmbH | 2003 | — |
| −2 | K040170 | Friadent Plus Dental Implant Systems | Friadent GmbH | 2004 | — |
| −1 | K102804 | Spi Titanium Base for Cad/Cam | Thommen Medical AG | 2011 | — |
| 0 (this device) | K122988 | Klockner Dental Implant Abutments | Soadco, S.L. | 2013 | — |
| +1 | K151194 | Klockner Dental Implant Abutments (II) | Soadco, S.L. | 2016 | — |
| +1 | K160221 | Implance Dental Implant System, Implance Dental Abutment System | Ags Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti. | 2016 | — |
| +1 | K160850 | Nucleoss Tpure Implant System | Sanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti | 2017 | — |
| +2 | K181266 | Implantswiss Dental Implant System, Implantswiss Dental Abutment System | Novodent SA | 2018 | — |
| +2 | K231100 | Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap… | Proimtech Saglik Urunleri Anonim Sirketi | 2024 | — |
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 |
|---|---|---|
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 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? (16)
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 |
|---|---|---|---|
| * | K080224 | Klockner Essential Dental Implants System, Models Essential Cone (EC), Essential Solid…Summary page 1…NHA Legally Marketed (Predicate) Device(s): 510(k) Number IDevice Manufacturer K080224 Klockner Essential Dental Implant System, models: EC, ES, ECK SOADCO K082200 Kiockner Essential Denta… | 2008 |
| * | K082200 | Klockner Essential Dental Implants System, Model Essential Cone 1.5Summary page 1…Manufacturer K080224 Klockner Essential Dental Implant System, models: EC, ES, ECK SOADCO K082200 Kiockner Essential Dental Implant System, model: EC 1.5 SOAOCO K010132 Klockner Dental Implants… | 2008 |
| * | K010132 | Klockner Dental Implants, Models SK, NK, IK, S3, and S4Summary page 1…sential Dental Implant System, models: EC, ES, ECK SOADCO K082200 Kiockner Essential Dental Implant System, model: EC 1.5 SOAOCO K010132 Klockner Dental Implants, models 51<2, NK2, S4 SOADGO K<062129 P.004 implants including… | 2002 |
| * | K062129 | P.0004 ImplantsSummary page 1…ntial Dental Implant System, model: EC 1.5 SOAOCO K010132 Klockner Dental Implants, models 51<2, NK2, S4 SOADGO K<062129 P.004 implants including abutments and healing caps Straumann K<071585 NC Healing Abutments a… | 2006 |
| * | K071585 | P.004 Healing Abutments and Closure ScrewsSummary page 1…Implants, models 51<2, NK2, S4 SOADGO K<062129 P.004 implants including abutments and healing caps Straumann K<071585 NC Healing Abutments and NC Closure Screws Straurnann K<033243 ITI synOcta (Esthetic… | 2007 |
| * | K033243 | Iti Synocta Meso AbutmentsSummary page 1…ding abutments and healing caps Straumann K<071585 NC Healing Abutments and NC Closure Screws Straurnann K<033243 ITI synOcta (Esthetic) Meso Abutments Straumann K<071357 P.004 NC Anatomic Abut… | 2003 |
| * | K071357 | P.004 NC Anatomic AbutmentsSummary page 1…and NC Closure Screws Straurnann K<033243 ITI synOcta (Esthetic) Meso Abutments Straumann K<071357 P.004 NC Anatomic Abutments Straumann K<050705 Tilnite implants… | 2007 |
| * | K050705 | Tiunite ImplantsSummary page 1…ic) Meso Abutments Straumann K<071357 P.004 NC Anatomic Abutments Straumann K<050705 Tilnite implants Nobel Biocare K<992334 TiN Coated Implant… | 2005 |
| * | K992334 | Endosseous Implants and Abutments- Tin CoatingSummary page 1…ents Straumann K<050705 Tilnite implants Nobel Biocare K<992334 TiN Coated Implants and Abutments 3i K<060291 PreFormance Temporary Cylinde… | 1999 |
| * | K060291 | Preformance Temporary CylinderSummary page 1…Nobel Biocare K<992334 TiN Coated Implants and Abutments 3i K<060291 PreFormance Temporary Cylinders 3i K<072624 Abutment for Provisional Rest… | 2006 |
| * | K072624 | Astra Tech Implant System, New ComponentSummary page 1…oated Implants and Abutments 3i K<060291 PreFormance Temporary Cylinders 3i K<072624 Abutment for Provisional Restorations Astra Tech K<092248 SPIQD Customnizable g… | 2007 |
| * | K092248 | Spi Customizable Gingiva FormerSummary page 1…emporary Cylinders 3i K<072624 Abutment for Provisional Restorations Astra Tech K<092248 SPIQD Customnizable gingiva former Thomnien Medical AG K<101798 SPI® Variomu… | 2009 |
| * | K101798 | Spi Variomulti Angled AbutmentSummary page 1…rations Astra Tech K<092248 SPIQD Customnizable gingiva former Thomnien Medical AG K<101798 SPI® Variomulti Angled abutment Thommen Medical AG K<083876 SF1-Bar®… | 2010 |
| * | K083876 | Sfi-Bar System Complete 2-Implant and 4-ImplantSummary page 1…Thomnien Medical AG K<101798 SPI® Variomulti Angled abutment Thommen Medical AG K<083876 SF1-Bar® Cendres & Mdtaux K102804 SPI® Titanium B… | 2010 |
| * | K102804 | Spi Titanium Base for Cad/CamSummary page 1…Thommen Medical AG K<083876 SF1-Bar® Cendres & Mdtaux K102804 SPI® Titanium Base for CADICAM Thommen Medical AG 1072055 Lavam Frame… | 2011 |
| * | K072055 | Lava Frame, Lava Frame ShadeSummary page 1…Cendres & Mdtaux K102804 SPI® Titanium Base for CADICAM Thommen Medical AG 1072055 Lavam Frame, Lava T"Frame Shade 3M ESPE AG… | 2008 |
What descends from it? (9)
3 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 23 years and passes through 6 companies; a new generation was cleared every 2.1 years on median.
- 14 of the 121 ancestors have a recall of any class.
- Of its descendants, K151194 (Soadco, S.L., 2016) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K080224.
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?
The Kiockner Dental Implant Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges or overdlentures. The Kiockner Dental Implant Abutments include healing caps, protective caps, temporary abutments, angled abutments, straight abutments, and overdlentures. All abutments are intended to be used with the Klockner Dental Implant Systems, models: Essential EC, Essential ES, Essential ECK, Essential EC 1.5, SK2 and NK2.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K122988 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122988: Klockner Dental Implant Abutments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122988
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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