510(k) · Cleared
ClearedModificaton to: Dentis 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 Jun 19, 2009 as substantially equivalent to K073465 (Osstem Implant Co., Ltd., 2008) after a 263-day review. Its family tree reaches back 8 generations to 1990. 1 later device descends from it.
- Decided
- Jun 19, 2009
- Review
- 263 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K894595 (1990). 19 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 7 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 6 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 5 generations backK011879 3A Dental Implant SystemOsseco Biosource, Ltd. · 2002
- 4 generations backK051576 Avana Dental Implant SystemOsstem Co., Ltd. · 2005
- 3 generations backK062051 SS SystemOsstem Implant Co., Ltd. · 2006
- 2 generations backK063861 GS SystemOsstem Implant Co., Ltd. · 2007
- 1 generation backK073465 US/GS Ultra Wide SystemOsstem Implant Co., Ltd. · 2008
- This deviceK082843 Modificaton to: Dentis Dental Implant SystemDentis Co., Ltd. · 2009
- Descendant · cites it directly · 0 of its ownK230126 Dentis s-Clean Regular AbutmentDentis Co., Ltd. · 2023
Most influential descendants
Showing 1 of 1 · See all- K230126Dentis s-Clean Regular AbutmentDentis Co., Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −7 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −6 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −5 | K011879 | 3A Dental Implant System | Osseco Biosource, Ltd. | 2002 | — |
| −4 | K051576 | Avana Dental Implant System | Osstem Co., Ltd. | 2005 | — |
| −3 | K062051 | SS System | Osstem Implant Co., Ltd. | 2006 | — |
| −2 | K063861 | GS System | Osstem Implant Co., Ltd. | 2007 | — |
| −1 | K073465 | US/GS Ultra Wide System | Osstem Implant Co., Ltd. | 2008 | — |
| 0 (this device) | K082843 | Modificaton to: Dentis Dental Implant System | Dentis Co., Ltd. | 2009 | — |
| +1 | K230126 | Dentis s-Clean Regular Abutment | Dentis Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 |
|---|---|---|---|
| * | K073465 | US/GS Ultra Wide SystemSummary page 2…standards. Predicate Devices The subject device is substantially equivalent to the following predicate devices: · US / GS Ultra Wide System (Osstem Co., Ltd. K073465) Comparison to Predicate Devices Testing and other comparisons have established that the subject of Dentis Dental Implant Syst… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230126 | Dentis s-Clean Regular Abutment | 2023 | 0 |
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 19 years and passes through 7 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 19 ancestors has a recall of any class.
- Of its descendants, K230126 (Dentis Co., Ltd., 2023) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K073465.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 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 and not for immediate load. Also, this
system is intended to be used in the molar region.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082843 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082843: Modificaton to: 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/K082843
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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