510(k) · Cleared
Cleareds-Clean TiN Coating Abutments
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 Nov 29, 2017 as substantially equivalent to K171027 (Dentis Co., Ltd., 2017) and 1 other predicate after a 175-day review. Its family tree reaches back 14 generations to 1990. 2 later devices descend from it.
- Decided
- Nov 29, 2017
- Review
- 175 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K894595 (1990). 118 ancestors in all, the oldest K874590 (1988). 2 later devices descend from it, 2 citing it directly.
- Root · 14 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 10 generations between
- 3 generations backK120847 ET/SS Implant SystemOsstem Implant Co., Ltd. · 2012
- 2 generations backK142313 OneQ-SL Implant SystemDentis Co., Ltd. · 2015
- 1 generation backK171027 Dentis Dental Implant SystemDentis Co., Ltd. · 2017
- This deviceK171694 s-Clean TiN Coating AbutmentsDentis Co., Ltd. · 2017
- Descendant · cites it directly · 0 of its ownK230126 Dentis s-Clean Regular AbutmentDentis Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK210080 Dentis s-Clean s-Line MiniDentis Co., Ltd. · 2021
Show all 14 generations
- Root · 14 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 13 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 12 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 11 generations backK011879 3A Dental Implant SystemOsseco Biosource, Ltd. · 2002
- 10 generations backK051576 Avana Dental Implant SystemOsstem Co., Ltd. · 2005
- 9 generations backK062051 SS SystemOsstem Implant Co., Ltd. · 2006
- 8 generations backK063861 GS SystemOsstem Implant Co., Ltd. · 2007
- 7 generations backK080744 HG II Fixture SystemOsstem Implant Co., Ltd. · 2008
- 6 generations backK082213 GS Iii Fixture SystemOsstem Implant Co., Ltd. · 2008
- 5 generations backK093352 HG Iii Fixture SystemHiossen, Inc. · 2009
- 4 generations backK101096 HT Iii SA Fixture SystemHiossen, Inc. · 2010
- 3 generations backK120847 ET/SS Implant SystemOsstem Implant Co., Ltd. · 2012
- 2 generations backK142313 OneQ-SL Implant SystemDentis Co., Ltd. · 2015
- 1 generation backK171027 Dentis Dental Implant SystemDentis Co., Ltd. · 2017
- This deviceK171694 s-Clean TiN Coating AbutmentsDentis Co., Ltd. · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −13 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −12 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −11 | K011879 | 3A Dental Implant System | Osseco Biosource, Ltd. | 2002 | — |
| −10 | K051576 | Avana Dental Implant System | Osstem Co., Ltd. | 2005 | — |
| −9 | K062051 | SS System | Osstem Implant Co., Ltd. | 2006 | — |
| −8 | K063861 | GS System | Osstem Implant Co., Ltd. | 2007 | — |
| −7 | K080744 | HG II Fixture System | Osstem Implant Co., Ltd. | 2008 | — |
| −6 | K082213 | GS Iii Fixture System | Osstem Implant Co., Ltd. | 2008 | — |
| −5 | K093352 | HG Iii Fixture System | Hiossen, Inc. | 2009 | — |
| −4 | K101096 | HT Iii SA Fixture System | Hiossen, Inc. | 2010 | — |
| −3 | K120847 | ET/SS Implant System | Osstem Implant Co., Ltd. | 2012 | — |
| −2 | K142313 | OneQ-SL Implant System | Dentis Co., Ltd. | 2015 | — |
| −1 | K171027 | Dentis Dental Implant System | Dentis Co., Ltd. | 2017 | — |
| 0 (this device) | K171694 | s-Clean TiN Coating Abutments | Dentis Co., Ltd. | 2017 | — |
| +1 | K230126 | Dentis s-Clean Regular Abutment | Dentis Co., Ltd. | 2023 | — |
| +1 | K210080 | Dentis s-Clean s-Line Mini | Dentis Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 10 | 0 |
| 1994 | 6 | 0 |
| 1995 | 6 | 0 |
| 1996 | 10 | 0 |
| 1997 | 7 | 0 |
| 1998 | 4 | 0 |
| 1999 | 6 | 0 |
| 2000 | 5 | 0 |
| 2001 | 6 | 0 |
| 2002 | 9 | 0 |
| 2003 | 3 | 0 |
| 2004 | 5 | 0 |
| 2005 | 1 | 0 |
| 2006 | 5 | 0 |
| 2007 | 3 | 0 |
| 2008 | 7 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 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? (2)
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 System Cleared while this submission was under review Summary page 5…es Implant Models Sizes Dentis Dental Implant System s-Clean Tapered Fixture Diameters: Ø 3.7, 4.3, 4.8, 5.5, 6.0 (K171027) s-Clean SAVE Fixture Length: 7, 8, 10, 12, 14mm Dentis Dental Implant System s-C… | 2017 |
| * | K142211 | OT EquatorSummary page 6…ng Implant System by Dentis Co., Ltd. • K161244, S-Clean Oneq-sl Narrow Implant System by Dentis Co., Ltd. • K153521, IH Prosthetic System by Sewon Medix Inc. • K142211, OT Equator by Rhein’83 Srl. Subject device Primary Predicate Reference Predicate… | 2015 |
| † | K082843 | Modificaton to: Dentis Dental Implant System | 2009 |
| † | K111364 | Haptite Coating Implant System | 2012 |
| † | K161244 | s-Clean OneQ-SL Narrow Implant System | 2016 |
| † | K153521 | IH Implant System | 2016 |
What descends from it? (2)
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 27 years and passes through 8 companies; a new generation was cleared every 1.2 years on median.
- 11 of the 118 ancestors have a recall of any class.
- Of its descendants, K230126 (Dentis Co., Ltd., 2023) has gone furthest, with 0 descendants of its own.
- 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. 2017, 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 s-Clean TiN Coating Abutments is an endosseous dental implant that is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple-units prosthetic appliance attachment to restore a patient’s chewing function. Implants can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.
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/K171694 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171694: s-Clean TiN Coating Abutments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171694
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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