510(k) · Cleared
ClearedOneQ-SL s-Clean Implant System
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 Apr 8, 2016 as substantially equivalent to K073486 (Dentis Co., Ltd., 2008) and 3 other predicates after a 109-day review. Its family tree reaches back 13 generations to 1990. 14 later devices descend from it.
- Decided
- Apr 8, 2016
- Review
- 109 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 13 generations to K894595 (1990). 97 ancestors in all, the oldest K874590 (1988). 14 later devices descend from it, 7 citing it directly.
- Root · 13 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 9 generations between
- 3 generations backK101096 HT Iii SA Fixture SystemHiossen, Inc. · 2010
- 2 generations backK120847 ET/SS Implant SystemOsstem Implant Co., Ltd. · 2012
- 1 generation backK142313 OneQ-SL Implant SystemDentis Co., Ltd. · 2015
- This deviceK153639 OneQ-SL s-Clean Implant SystemDentis Co., Ltd. · 2016
- Descendant · cites it directly · 3 of its ownK192688 s-Clean SQ-SL Implant System RegularDentis Co., Ltd. · 2020
- Descendant · cites it directly · 2 of its ownK210134 Dentis s-Clean s-LineDentis Co., Ltd. · 2021
- Descendant · cites it directly · 1 of its ownK212517 Magicore SystemInnobiosurg Co., Ltd. · 2021
- Descendant · cites it directly · 1 of its ownK200099 s-Clean SQ-SL Implant System MiniDentis Co., Ltd. · 2020
- Descendant · 2 generations on · 0 of its ownK253493 Dentis SQ-SL AXEL FixtureDentis Co., Ltd. · 2026
Show all 13 generations
- Root · 13 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 12 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 11 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 10 generations backK011879 3A Dental Implant SystemOsseco Biosource, Ltd. · 2002
- 9 generations backK051576 Avana Dental Implant SystemOsstem Co., Ltd. · 2005
- 8 generations backK062051 SS SystemOsstem Implant Co., Ltd. · 2006
- 7 generations backK063861 GS SystemOsstem Implant Co., Ltd. · 2007
- 6 generations backK080744 HG II Fixture SystemOsstem Implant Co., Ltd. · 2008
- 5 generations backK082213 GS Iii Fixture SystemOsstem Implant Co., Ltd. · 2008
- 4 generations backK093352 HG Iii Fixture SystemHiossen, Inc. · 2009
- 3 generations backK101096 HT Iii SA Fixture SystemHiossen, Inc. · 2010
- 2 generations backK120847 ET/SS Implant SystemOsstem Implant Co., Ltd. · 2012
- 1 generation backK142313 OneQ-SL Implant SystemDentis Co., Ltd. · 2015
- This deviceK153639 OneQ-SL s-Clean Implant SystemDentis Co., Ltd. · 2016
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K192688s-Clean SQ-SL Implant System RegularDentis Co., Ltd. · 2020 · cites it directly3descendants
- K210134Dentis s-Clean s-LineDentis Co., Ltd. · 2021 · cites it directly2descendants
- K212517Magicore SystemInnobiosurg Co., Ltd. · 2021 · cites it directly1descendant
- K200099s-Clean SQ-SL Implant System MiniDentis Co., Ltd. · 2020 · cites it directly1descendant
- K253493Dentis SQ-SL AXEL FixtureDentis Co., Ltd. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −12 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −11 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −10 | K011879 | 3A Dental Implant System | Osseco Biosource, Ltd. | 2002 | — |
| −9 | K051576 | Avana Dental Implant System | Osstem Co., Ltd. | 2005 | — |
| −8 | K062051 | SS System | Osstem Implant Co., Ltd. | 2006 | — |
| −7 | K063861 | GS System | Osstem Implant Co., Ltd. | 2007 | — |
| −6 | K080744 | HG II Fixture System | Osstem Implant Co., Ltd. | 2008 | — |
| −5 | K082213 | GS Iii Fixture System | Osstem Implant Co., Ltd. | 2008 | — |
| −4 | K093352 | HG Iii Fixture System | Hiossen, Inc. | 2009 | — |
| −3 | K101096 | HT Iii SA Fixture System | Hiossen, Inc. | 2010 | — |
| −2 | K120847 | ET/SS Implant System | Osstem Implant Co., Ltd. | 2012 | — |
| −1 | K142313 | OneQ-SL Implant System | Dentis Co., Ltd. | 2015 | — |
| 0 (this device) | K153639 | OneQ-SL s-Clean Implant System | Dentis Co., Ltd. | 2016 | — |
| +1 | K192688 | s-Clean SQ-SL Implant System Regular | Dentis Co., Ltd. | 2020 | — |
| +1 | K210134 | Dentis s-Clean s-Line | Dentis Co., Ltd. | 2021 | — |
| +1 | K212517 | Magicore System | Innobiosurg Co., Ltd. | 2021 | — |
| +1 | K200099 | s-Clean SQ-SL Implant System Mini | Dentis Co., Ltd. | 2020 | — |
| +2 | K253493 | Dentis SQ-SL AXEL Fixture | Dentis Co., Ltd. | 2026 | — |
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 | 9 | 0 |
| 1997 | 3 | 0 |
| 1998 | 4 | 0 |
| 1999 | 4 | 0 |
| 2000 | 5 | 0 |
| 2001 | 5 | 0 |
| 2002 | 6 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 6 | 0 |
| 2007 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 5 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 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? (4)
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 |
|---|---|---|---|
| * | K073486 | Dentis Dental Implant SystemSummary page 4…t. The OneQ-SL s-Clean Implant system is substantially equivalent in connection structure, similar design, function and intended use to the Dentis dental implant system (K073486) of DENTIS Co., Ltd., and Dentis dental implant system(K150344) of DENTIS Co., Ltd. The difference between the subject and the pr… | 2008 |
| * | K150344 | Dentis Dental Implant SystemSummary page 4…nt in connection structure, similar design, function and intended use to the Dentis dental implant system (K073486) of DENTIS Co., Ltd., and Dentis dental implant system(K150344) of DENTIS Co., Ltd. The difference between the subject and the predicate device are slightly different shape and surface treatme… | 2015 |
| * | K142313 | OneQ-SL Implant SystemSummary page 6…e subject device is substantially equivalent to the following predicate devices: K150344/K073486, Dentis Dental Implant System manufactured by Dentis Co., Ltd. K142313, OneQ-SL Implant System manufactured by Dentis. Co., Ltd. K063216, Rescue Internal Dental Implant System by Megagen Co., Ltd… | 2015 |
| * | K063216 | Rescue Internal Implant SystemSummary page 6…devices: K150344/K073486, Dentis Dental Implant System manufactured by Dentis Co., Ltd. K142313, OneQ-SL Implant System manufactured by Dentis. Co., Ltd. K063216, Rescue Internal Dental Implant System by Megagen Co., Ltd. Division Subject Device Pr… | 2007 |
What descends from it? (14)
See all 147 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 8 companies; a new generation was cleared every 1.1 years on median.
- 6 of the 97 ancestors have a recall of any class.
- Of its descendants, K192688 (Dentis Co., Ltd., 2020) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K073486.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
The OneQ-SL s-Clean Implant System 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/K153639 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153639: OneQ-SL s-Clean Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153639
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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