510(k) · Cleared
ClearedDentis SQ-SL AXEL Fixture
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 Mar 4, 2026 as substantially equivalent to K192688 (Dentis Co., Ltd., 2020) after a 128-day review. Its family tree reaches back 15 generations to 1990.
- Decided
- Mar 4, 2026
- Review
- 128 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K894595 (1990). 99 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 backK153639 OneQ-SL s-Clean Implant SystemDentis Co., Ltd. · 2016
- 1 generation backK192688 s-Clean SQ-SL Implant System RegularDentis Co., Ltd. · 2020
- This deviceK253493 Dentis SQ-SL AXEL FixtureDentis Co., Ltd. · 2026
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 backK153639 OneQ-SL s-Clean Implant SystemDentis Co., Ltd. · 2016
- 1 generation backK192688 s-Clean SQ-SL Implant System RegularDentis Co., Ltd. · 2020
- This deviceK253493 Dentis SQ-SL AXEL FixtureDentis Co., Ltd. · 2026
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 | K153639 | OneQ-SL s-Clean Implant System | Dentis Co., Ltd. | 2016 | — |
| −1 | K192688 | s-Clean SQ-SL Implant System Regular | Dentis Co., Ltd. | 2020 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K192688 | s-Clean SQ-SL Implant System RegularSummary page 5…uct Code: DZE • Panel: Dental • Regulation Number: 872.3640 • Device Class: Class II • Date Prepared: 03/03/2026 Predicate Devices: Primary Predicate • K192688, s-Clean SQ-SL Implant System Regular by Dentis Co., Ltd. Reference Device • K140934, HIOSSEN Implant System by HIOSSEN, Inco… | 2020 |
| † | K140934 | Hiossen Implant System | 2014 |
| † | K153639 | OneQ-SL s-Clean Implant System | 2016 |
| † | K202773 | s-Clean SQ-SL Implant System Mini | 2021 |
| † | K210080 | Dentis s-Clean s-Line Mini | 2021 |
| † | K210134 | Dentis s-Clean s-Line | 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 36 years and passes through 8 companies; a new generation was cleared every 1.2 years on median.
- 6 of the 99 ancestors have a recall of any class.
- 2 other devices also cite its predicate K192688.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 SQ -SL AXEL Fixture 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K253493 · printed Nov 5, 2026
Cite this page
510(k) Report. “K253493: Dentis SQ-SL AXEL Fixture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K253493
Report an extraction error
Are you the manufacturer?
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