510(k) · Cleared
ClearedDentis Dental 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 Sep 6, 2017 as substantially equivalent to K073486 (Dentis Co., Ltd., 2008) and 3 other predicates after a 154-day review. Its family tree reaches back 13 generations to 1990. 5 later devices descend from it.
- Decided
- Sep 6, 2017
- Review
- 154 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 13 generations to K894595 (1990). 114 ancestors in all, the oldest K874590 (1988). 5 later devices descend from it, 5 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 deviceK171027 Dentis Dental Implant SystemDentis Co., Ltd. · 2017
- Descendant · cites it directly · 2 of its ownK171694 s-Clean TiN Coating AbutmentsDentis Co., Ltd. · 2017
- Descendant · cites it directly · 0 of its ownK252286 BIORES Dental Implant SystemChengdu Besmile Medical Technology Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK230126 Dentis s-Clean Regular AbutmentDentis Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK220440 Dentis s-Clean Abutment MiniDentis Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK210080 Dentis s-Clean s-Line MiniDentis Co., Ltd. · 2021
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 deviceK171027 Dentis Dental Implant SystemDentis Co., Ltd. · 2017
Most influential descendants
Showing 5 of 5 · See all- K171694s-Clean TiN Coating AbutmentsDentis Co., Ltd. · 2017 · cites it directly2descendants
- K252286BIORES Dental Implant SystemChengdu Besmile Medical Technology Co., Ltd. · 2026 · cites it directly0descendants
- K230126Dentis s-Clean Regular AbutmentDentis Co., Ltd. · 2023 · cites it directly0descendants
- K220440Dentis s-Clean Abutment MiniDentis Co., Ltd. · 2022 · cites it directly0descendants
- K210080Dentis s-Clean s-Line MiniDentis Co., Ltd. · 2021 · cites it directly0descendants
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) | K171027 | Dentis Dental Implant System | Dentis Co., Ltd. | 2017 | — |
| +1 | K171694 | s-Clean TiN Coating Abutments | Dentis Co., Ltd. | 2017 | — |
| +1 | K252286 | BIORES Dental Implant System | Chengdu Besmile Medical Technology Co., Ltd. | 2026 | — |
| +1 | K230126 | Dentis s-Clean Regular Abutment | Dentis Co., Ltd. | 2023 | — |
| +1 | K220440 | Dentis s-Clean Abutment Mini | Dentis Co., Ltd. | 2022 | — |
| +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 | 6 | 0 |
| 1998 | 4 | 0 |
| 1999 | 6 | 0 |
| 2000 | 5 | 0 |
| 2001 | 6 | 0 |
| 2002 | 9 | 0 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 5 | 0 |
| 2007 | 3 | 0 |
| 2008 | 7 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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…hree system, i-Clean System, s-Clean System, and e-Clean System. The purpose of this submission is to add various fixtures and abutment to the previously cleared device, K073486. Also, various set packing codes have been changed and it applies to the subject submission. Each system in the submission includ… | 2008 |
| * | K142313 | OneQ-SL Implant SystemSummary page 7…he subject device is substantially equivalent to the following predicate devices: • K073486, Dentis Dental Implant System by Dentis Co., Ltd. - Primary predicate • K142313, OneQ-SL s-Clean Implant System by Dentis Co., Ltd. • K161244, s-Clean OneQ-SL Narrow System by Dentis Co., Ltd. ① Fixtur… | 2015 |
| * | K161244 | s-Clean OneQ-SL Narrow Implant SystemSummary page 7…edicate devices: • K073486, Dentis Dental Implant System by Dentis Co., Ltd. - Primary predicate • K142313, OneQ-SL s-Clean Implant System by Dentis Co., Ltd. • K161244, s-Clean OneQ-SL Narrow System by Dentis Co., Ltd. ① Fixtures a. i-Clean System Subject device… | 2016 |
| * | K150344 | Dentis Dental Implant SystemSummary page 17…Subject Device Previously Cleared Product 510(K) Number K171027 K150344 Manufacturer Dentis Co., Ltd Dentis Co., Ltd. Device Name… | 2015 |
| † | K153639 | OneQ-SL s-Clean Implant System | 2016 |
What descends from it? (5)
5 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 114 ancestors have a recall of any class.
- Of its descendants, K171694 (Dentis Co., Ltd., 2017) has gone furthest, with 2 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. 2017, 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 Dentis Dental Implant System 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 inmediate 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/K171027 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171027: Dentis Dental 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/K171027
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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