510(k) · Cleared
ClearedDentis s-Clean Regular Abutment
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentis Co., Ltd. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Aug 4, 2023 as substantially equivalent to K171027 (Dentis Co., Ltd., 2017) and 6 other predicates after a 199-day review. Its family tree reaches back 15 generations to 1990.
- Decided
- Aug 4, 2023
- Review
- 199 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 15 generations to K894595 (1990). 153 ancestors in all, the oldest K874590 (1988). No later device cites it as a predicate yet.
- Root · 15 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 11 generations between
- 3 generations backK142313 OneQ-SL Implant SystemDentis Co., Ltd. · 2015
- 2 generations backK171027 Dentis Dental Implant SystemDentis Co., Ltd. · 2017
- 1 generation backK171694 s-Clean TiN Coating AbutmentsDentis Co., Ltd. · 2017
- This deviceK230126 Dentis s-Clean Regular AbutmentDentis Co., Ltd. · 2023
Show all 15 generations
- Root · 15 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 14 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 13 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 12 generations backK011879 3A Dental Implant SystemOsseco Biosource, Ltd. · 2002
- 11 generations backK051576 Avana Dental Implant SystemOsstem Co., Ltd. · 2005
- 10 generations backK062051 SS SystemOsstem Implant Co., Ltd. · 2006
- 9 generations backK063861 GS SystemOsstem Implant Co., Ltd. · 2007
- 8 generations backK080744 HG II Fixture SystemOsstem Implant Co., Ltd. · 2008
- 7 generations backK082213 GS Iii Fixture SystemOsstem Implant Co., Ltd. · 2008
- 6 generations backK093352 HG Iii Fixture SystemHiossen, Inc. · 2009
- 5 generations backK101096 HT Iii SA Fixture SystemHiossen, Inc. · 2010
- 4 generations backK120847 ET/SS Implant SystemOsstem Implant Co., Ltd. · 2012
- 3 generations backK142313 OneQ-SL Implant SystemDentis Co., Ltd. · 2015
- 2 generations backK171027 Dentis Dental Implant SystemDentis Co., Ltd. · 2017
- 1 generation backK171694 s-Clean TiN Coating AbutmentsDentis Co., Ltd. · 2017
- This deviceK230126 Dentis s-Clean Regular AbutmentDentis Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −14 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −13 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −12 | K011879 | 3A Dental Implant System | Osseco Biosource, Ltd. | 2002 | — |
| −11 | K051576 | Avana Dental Implant System | Osstem Co., Ltd. | 2005 | — |
| −10 | K062051 | SS System | Osstem Implant Co., Ltd. | 2006 | — |
| −9 | K063861 | GS System | Osstem Implant Co., Ltd. | 2007 | — |
| −8 | K080744 | HG II Fixture System | Osstem Implant Co., Ltd. | 2008 | — |
| −7 | K082213 | GS Iii Fixture System | Osstem Implant Co., Ltd. | 2008 | — |
| −6 | K093352 | HG Iii Fixture System | Hiossen, Inc. | 2009 | — |
| −5 | K101096 | HT Iii SA Fixture System | Hiossen, Inc. | 2010 | — |
| −4 | K120847 | ET/SS Implant System | Osstem Implant Co., Ltd. | 2012 | — |
| −3 | K142313 | OneQ-SL Implant System | Dentis Co., Ltd. | 2015 | — |
| −2 | K171027 | Dentis Dental Implant System | Dentis Co., Ltd. | 2017 | — |
| −1 | K171694 | s-Clean TiN Coating Abutments | Dentis Co., Ltd. | 2017 | — |
| 0 (this device) | K230126 | Dentis s-Clean Regular Abutment | Dentis Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 11 | 0 |
| 1994 | 6 | 0 |
| 1995 | 7 | 0 |
| 1996 | 11 | 0 |
| 1997 | 7 | 0 |
| 1998 | 4 | 0 |
| 1999 | 7 | 0 |
| 2000 | 5 | 0 |
| 2001 | 9 | 0 |
| 2002 | 12 | 0 |
| 2003 | 4 | 0 |
| 2004 | 7 | 0 |
| 2005 | 3 | 0 |
| 2006 | 8 | 0 |
| 2007 | 6 | 0 |
| 2008 | 8 | 0 |
| 2009 | 2 | 0 |
| 2010 | 4 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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? (7)
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 |
|---|---|---|---|
| * | K171027 | Dentis Dental Implant SystemSummary page 4…: Class II • Date Prepared: 08/04/2023 Predicate Devices: The subject device is substantially equivalent to the following predicate devices: Primary Predicate • K171027, Dentis Dental Implant System manufactured by Dentis Co., Ltd. Reference devices • K082843, Dentis Dental Implant System manu… | 2017 |
| * | K082843 | Modificaton to: Dentis Dental Implant SystemSummary page 4…lly equivalent to the following predicate devices: Primary Predicate • K171027, Dentis Dental Implant System manufactured by Dentis Co., Ltd. Reference devices • K082843, Dentis Dental Implant System manufactured by Dentis Co., Ltd • K111364, HAPTITE COATING IMPLANT SYSTEM by Dentis Co., Ltd.… | 2009 |
| * | K150344 | Dentis Dental Implant SystemSummary page 4…Ltd. Reference devices • K082843, Dentis Dental Implant System manufactured by Dentis Co., Ltd • K111364, HAPTITE COATING IMPLANT SYSTEM by Dentis Co., Ltd. • K150344, Dentis Dental Implant System manufactured by Dentis Co., Ltd. • K161689, OSSTEM Implant System manufactured by Osstem Implant… | 2015 |
| * | K210134 | Dentis s-Clean s-LineSummary page 4…is Co., Ltd. • K161689, OSSTEM Implant System manufactured by Osstem Implant Co., Ltd • K171694, s-Clean TiN Coating Abutment manufactured by Dentis Co., Ltd. • K210134, Dentis s-Clean s-Line manufactured by Dentis Co., Ltd. • K210826, Healing Abutment, Cover Screw manufactured by Megagen Impla… | 2021 |
| * | K171694 | s-Clean TiN Coating AbutmentsSummary page 4…is Co., Ltd. • K150344, Dentis Dental Implant System manufactured by Dentis Co., Ltd. • K161689, OSSTEM Implant System manufactured by Osstem Implant Co., Ltd • K171694, s-Clean TiN Coating Abutment manufactured by Dentis Co., Ltd. • K210134, Dentis s-Clean s-Line manufactured by Dentis Co., Lt… | 2017 |
| * | K161689 | OSSTEM Implant System - AbutmentSummary page 4…ured by Dentis Co., Ltd • K111364, HAPTITE COATING IMPLANT SYSTEM by Dentis Co., Ltd. • K150344, Dentis Dental Implant System manufactured by Dentis Co., Ltd. • K161689, OSSTEM Implant System manufactured by Osstem Implant Co., Ltd • K171694, s-Clean TiN Coating Abutment manufactured by Dentis… | 2017 |
| * | K210826 | Healing Abutment, Cover ScrewSummary page 4…em Implant Co., Ltd • K171694, s-Clean TiN Coating Abutment manufactured by Dentis Co., Ltd. • K210134, Dentis s-Clean s-Line manufactured by Dentis Co., Ltd. • K210826, Healing Abutment, Cover Screw manufactured by Megagen Implant Co., Ltd. • K222913, s-Clean Link Abutment by Dentis Co., Ltd.… | 2022 |
| † | K111364 | Haptite Coating Implant System | 2012 |
| † | K222913 | s-Clean Link Abutment | 2023 |
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 8 companies; a new generation was cleared every 1.2 years on median.
- 15 of the 153 ancestors have a recall of any class.
- 4 other devices also cite its predicate K171027.
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?
Dentis s-Clean Regular Abutment is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230126 · printed Nov 5, 2026
Cite this page
510(k) Report. “K230126: Dentis s-Clean Regular Abutment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K230126
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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