510(k) · Cleared
ClearedOneQ-SL 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 Dec 10, 2015 as substantially equivalent to K120847 (Osstem Implant Co., Ltd., 2012) after a 478-day review. Its family tree reaches back 12 generations to 1990. 19 later devices descend from it.
- Decided
- Dec 10, 2015
- Review
- 478 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K894595 (1990). 46 ancestors in all. 19 later devices descend from it, 2 citing it directly.
- Root · 12 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 8 generations between
- 3 generations backK093352 HG Iii Fixture SystemHiossen, Inc. · 2009
- 2 generations backK101096 HT Iii SA Fixture SystemHiossen, Inc. · 2010
- 1 generation backK120847 ET/SS Implant SystemOsstem Implant Co., Ltd. · 2012
- This deviceK142313 OneQ-SL Implant SystemDentis Co., Ltd. · 2015
- Descendant · cites it directly · 14 of its ownK153639 OneQ-SL s-Clean Implant SystemDentis Co., Ltd. · 2016
- Descendant · cites it directly · 5 of its ownK171027 Dentis Dental Implant SystemDentis Co., Ltd. · 2017
- Descendant · 2 generations on · 3 of its ownK192688 s-Clean SQ-SL Implant System RegularDentis Co., Ltd. · 2020
- Descendant · 2 generations on · 2 of its ownK210134 Dentis s-Clean s-LineDentis Co., Ltd. · 2021
- Descendant · 2 generations on · 2 of its ownK171694 s-Clean TiN Coating AbutmentsDentis Co., Ltd. · 2017
Show all 12 generations
- Root · 12 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 11 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 10 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 9 generations backK011879 3A Dental Implant SystemOsseco Biosource, Ltd. · 2002
- 8 generations backK051576 Avana Dental Implant SystemOsstem Co., Ltd. · 2005
- 7 generations backK062051 SS SystemOsstem Implant Co., Ltd. · 2006
- 6 generations backK063861 GS SystemOsstem Implant Co., Ltd. · 2007
- 5 generations backK080744 HG II Fixture SystemOsstem Implant Co., Ltd. · 2008
- 4 generations backK082213 GS Iii Fixture SystemOsstem Implant Co., Ltd. · 2008
- 3 generations backK093352 HG Iii Fixture SystemHiossen, Inc. · 2009
- 2 generations backK101096 HT Iii SA Fixture SystemHiossen, Inc. · 2010
- 1 generation backK120847 ET/SS Implant SystemOsstem Implant Co., Ltd. · 2012
- This deviceK142313 OneQ-SL Implant SystemDentis Co., Ltd. · 2015
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K153639OneQ-SL s-Clean Implant SystemDentis Co., Ltd. · 2016 · cites it directly14descendants
- K171027Dentis Dental Implant SystemDentis Co., Ltd. · 2017 · cites it directly5descendants
- K192688s-Clean SQ-SL Implant System RegularDentis Co., Ltd. · 2020 · 2 generations on3descendants
- K210134Dentis s-Clean s-LineDentis Co., Ltd. · 2021 · 2 generations on2descendants
- K171694s-Clean TiN Coating AbutmentsDentis Co., Ltd. · 2017 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −11 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −10 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −9 | K011879 | 3A Dental Implant System | Osseco Biosource, Ltd. | 2002 | — |
| −8 | K051576 | Avana Dental Implant System | Osstem Co., Ltd. | 2005 | — |
| −7 | K062051 | SS System | Osstem Implant Co., Ltd. | 2006 | — |
| −6 | K063861 | GS System | Osstem Implant Co., Ltd. | 2007 | — |
| −5 | K080744 | HG II Fixture System | Osstem Implant Co., Ltd. | 2008 | — |
| −4 | K082213 | GS Iii Fixture System | Osstem Implant Co., Ltd. | 2008 | — |
| −3 | K093352 | HG Iii Fixture System | Hiossen, Inc. | 2009 | — |
| −2 | K101096 | HT Iii SA Fixture System | Hiossen, Inc. | 2010 | — |
| −1 | K120847 | ET/SS Implant System | Osstem Implant Co., Ltd. | 2012 | — |
| 0 (this device) | K142313 | OneQ-SL Implant System | Dentis Co., Ltd. | 2015 | — |
| +1 | K153639 | OneQ-SL s-Clean Implant System | Dentis Co., Ltd. | 2016 | — |
| +1 | K171027 | Dentis Dental Implant System | Dentis Co., Ltd. | 2017 | — |
| +2 | K192688 | s-Clean SQ-SL Implant System Regular | Dentis Co., Ltd. | 2020 | — |
| +2 | K210134 | Dentis s-Clean s-Line | Dentis Co., Ltd. | 2021 | — |
| +2 | K171694 | s-Clean TiN Coating Abutments | Dentis Co., Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 5 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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? (1)
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 |
|---|---|---|---|
| * | K120847 | ET/SS Implant SystemSummary page 5…rk. This system is intended for delayed loading. Predicate Devices & Comparison The subject device is substantially equivalent to the following predicate devices: • K120847, ET/SS Implant System manufactured by Osstem Implant Co., Ltd. Subject Device… | 2012 |
What descends from it? (19)
See all 192 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 25 years and passes through 8 companies; a new generation was cleared every 1.2 years on median.
- 2 of the 46 ancestors have a recall of any class.
- Of its descendants, K153639 (Dentis Co., Ltd., 2016) has gone furthest, with 14 descendants of its own.
- 10 other devices also cite its predicate K120847.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 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 intended for delayed 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/K142313 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142313: OneQ-SL 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/K142313
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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