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 Jul 24, 2015 as substantially equivalent to K073486 (Dentis Co., Ltd., 2008) after a 163-day review. Its family tree reaches back 9 generations to 1995. 20 later devices descend from it.
- Decided
- Jul 24, 2015
- Review
- 163 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K944964 (1995). 57 ancestors in all, the oldest K874590 (1988). 20 later devices descend from it, 5 citing it directly.
- Root · 9 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 5 generations between
- 3 generations backK052369 Exfeel Implant SystemMegagen Co., Ltd. · 2006
- 2 generations backK070562 EZ Plus Implant SystemMegagen Co., Ltd. · 2007
- 1 generation backK073486 Dentis Dental Implant SystemDentis Co., Ltd. · 2008
- This deviceK150344 Dentis Dental 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 9 generations
- Root · 9 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 8 generations backK961728 Miruscone Abutment SystemNobelpharma USA, Inc. · 1996
- 7 generations backK962403 Noblepharma Wide AccessoriesNobelpharma USA, Inc. · 1996
- 6 generations backK971706 Tiadapt Abutment SystemNobel Biocare Uas, Inc. · 1997
- 5 generations backK974150 Procera Preparable Abutment SystemNobel Biocare Uas, Inc. · 1998 · Recalled
- 4 generations backK041655 Bio Plant System (Implants and Abutments)Cowellmedi Co., Ltd. · 2004
- 3 generations backK052369 Exfeel Implant SystemMegagen Co., Ltd. · 2006
- 2 generations backK070562 EZ Plus Implant SystemMegagen Co., Ltd. · 2007
- 1 generation backK073486 Dentis Dental Implant SystemDentis Co., Ltd. · 2008
- This deviceK150344 Dentis Dental Implant SystemDentis Co., Ltd. · 2015
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · 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 |
|---|---|---|---|---|---|
| −9 | K944964 | Branemark System Miruscone Abutment System | Nobelpharma USA, Inc. | 1995 | — |
| −8 | K961728 | Miruscone Abutment System | Nobelpharma USA, Inc. | 1996 | — |
| −7 | K962403 | Noblepharma Wide Accessories | Nobelpharma USA, Inc. | 1996 | — |
| −6 | K971706 | Tiadapt Abutment System | Nobel Biocare Uas, Inc. | 1997 | — |
| −5 | K974150 | Procera Preparable Abutment System | Nobel Biocare Uas, Inc. | 1998 | 2 |
| −4 | K041655 | Bio Plant System (Implants and Abutments) | Cowellmedi Co., Ltd. | 2004 | — |
| −3 | K052369 | Exfeel Implant System | Megagen Co., Ltd. | 2006 | — |
| −2 | K070562 | EZ Plus Implant System | Megagen Co., Ltd. | 2007 | — |
| −1 | K073486 | Dentis Dental Implant System | Dentis Co., Ltd. | 2008 | — |
| 0 (this device) | K150344 | Dentis Dental 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 |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 10 | 0 |
| 1994 | 5 | 0 |
| 1995 | 5 | 0 |
| 1996 | 5 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 5 | 0 |
| 2001 | 2 | 0 |
| 2002 | 4 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 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 |
|---|---|---|---|
| * | K073486 | Dentis Dental Implant SystemSummary page 6…e used to support the decision of substantial equivalence. Predicate Devices: The subject device is substantially equivalent to the following predicate device: K073486, Dentis Dental Implant System manufactured by Dentis Co., Ltd. Comparison to Predicate Device: 1) Fixture… | 2008 |
What descends from it? (20)
See all 205 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 20 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 5 of the 57 ancestors have a recall of any class.
- Of its descendants, K153639 (Dentis Co., Ltd., 2016) has gone furthest, with 14 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. 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 Dentis Dental Implant System is an endosseous dental implant 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 immediate loading. Immediate loading is restricted to the anterior mandible based on four splinted interforminal placed implants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150344 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150344: 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/K150344
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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