510(k) · Cleared
ClearedDentis s-Clean s-Line Mini
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentis Co., Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Jun 4, 2021 as substantially equivalent to K153639 (Dentis Co., Ltd., 2016) and 2 other predicates after a 143-day review. Its family tree reaches back 15 generations to 1990.
- Decided
- Jun 4, 2021
- Review
- 143 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 15 generations to K894595 (1990). 124 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 deviceK210080 Dentis s-Clean s-Line MiniDentis Co., Ltd. · 2021
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 deviceK210080 Dentis s-Clean s-Line MiniDentis Co., Ltd. · 2021
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) | 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 | 10 | 0 |
| 2003 | 3 | 0 |
| 2004 | 5 | 0 |
| 2005 | 2 | 0 |
| 2006 | 6 | 0 |
| 2007 | 4 | 0 |
| 2008 | 7 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 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 DZE? 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 DZE device
- #1 K211090 ZENEX Implant Systemscore 25.4 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K153639 | OneQ-SL s-Clean Implant SystemSummary page 4…uct Code: NHA • Panel: Dental • Regulation Number: 872.3640 • Device Class: Class II • Date Prepared: 06/04/2021 Predicate Devices: Primary Predicate • K153639, Dentis Dental Implant System manufactured by Dentis Co., Ltd. Reference devices • K123155, Luna Dental Implant System manufa… | 2016 |
| * | K171027 | Dentis Dental Implant SystemSummary page 4…plant Co., Ltd • K150344, Dentis Dental Implant System manufactured by Dentis Co., Ltd. • K161689, OSSTEM Implant System – Abutment by OSSTEM Implant Co., Ltd • K171027, Dentis Dental Implant System manufactured by Dentis Co., Ltd. • K171694, s-Clean TiN Coating Abutment manufactured by Dentis… | 2017 |
| * | K171694 | s-Clean TiN Coating AbutmentsSummary page 4…ntis Co., Ltd. • K161689, OSSTEM Implant System – Abutment by OSSTEM Implant Co., Ltd • K171027, Dentis Dental Implant System manufactured by Dentis Co., Ltd. • K171694, s-Clean TiN Coating Abutment manufactured by Dentis Co., Ltd. • K192436, Healing Abutments and Cover Screws manufactured by D… | 2017 |
| † | K123155 | Luna Dental Implant System | 2013 |
| † | K123988 | Anyonetm Internal Implant System | 2013 |
| † | K150344 | Dentis Dental Implant System | 2015 |
| † | K161689 | OSSTEM Implant System - Abutment | 2017 |
| † | K192436 | Healing Abutments and Cover Screws | 2020 |
| † | K200099 | s-Clean SQ-SL Implant System Mini | 2020 |
| † | K202773 | s-Clean SQ-SL Implant System Mini | 2021 |
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 31 years and passes through 8 companies; a new generation was cleared every 1.2 years on median.
- 11 of the 124 ancestors have a recall of any class.
- 6 other devices also cite its predicate K153639.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · DZE
31in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZE
184in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZE
465,788in 2025
MAUDE reports naming product code DZE, 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 | 43 | 107 | 11 | 225 |
| 2008 | 61 | 118 | 4 | 393 |
| 2009 | 41 | 110 | 3 | 164 |
| 2010 | 34 | 162 | 3 | 360 |
| 2011 | 26 | 194 | 0 | 362 |
| 2012 | 39 | 174 | 11 | 358 |
| 2013 | 42 | 195 | 1 | 391 |
| 2014 | 36 | 265 | 7 | 1,124 |
| 2015 | 36 | 215 | 3 | 2,894 |
| 2016 | 40 | 219 | 15 | 1,116 |
| 2017 | 48 | 223 | 4 | 9,719 |
| 2018 | 41 | 200 | 4 | 12,892 |
| 2019 | 31 | 231 | 8 | 167,016 |
| 2020 | 41 | 230 | 0 | 255,524 |
| 2021 | 34 | 182 | 6 | 479,618 |
| 2022 | 34 | 243 | 0 | 483,224 |
| 2023 | 35 | 248 | 0 | 537,585 |
| 2024 | 40 | 222 | 1 | 473,629 |
| 2025 | 31 | 184 | 1 | 465,788 |
| 2026 | 15 | 194 | 2 | — |
What is it indicated for?
Dentis s-Clean s-Line Mini 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/K210080 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210080: Dentis s-Clean s-Line Mini.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210080
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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