510(k) · Cleared
ClearedImplantswiss Dental Implant System and Implantswiss Dental Abutment System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novodent SA · DZE Implant, Endosseous, Root-Form
Cleared on Apr 28, 2020 as substantially equivalent to K181266 (Novodent SA, 2018) after a 27-day review. Its family tree reaches back 11 generations to 1995.
- Decided
- Apr 28, 2020
- Review
- 27 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K944964 (1995). 143 ancestors in all, the oldest K820013 (1982). No later device cites it as a predicate yet.
- Root · 11 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 7 generations between
- 3 generations backK073486 Dentis Dental Implant SystemDentis Co., Ltd. · 2008
- 2 generations backK160221 Implance Dental Implant System, Implance Dental Abutment SystemAgs Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti. · 2016
- 1 generation backK181266 Implantswiss Dental Implant System, Implantswiss Dental Abutment…Novodent SA · 2018
- This deviceK200867 Implantswiss Dental Implant System and Implantswiss Dental Abutment…Novodent SA · 2020
Show all 11 generations
- Root · 11 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 10 generations backK961728 Miruscone Abutment SystemNobelpharma USA, Inc. · 1996
- 9 generations backK962403 Noblepharma Wide AccessoriesNobelpharma USA, Inc. · 1996
- 8 generations backK971706 Tiadapt Abutment SystemNobel Biocare Uas, Inc. · 1997
- 7 generations backK974150 Procera Preparable Abutment SystemNobel Biocare Uas, Inc. · 1998 · Recalled
- 6 generations backK041655 Bio Plant System (Implants and Abutments)Cowellmedi Co., Ltd. · 2004
- 5 generations backK052369 Exfeel Implant SystemMegagen Co., Ltd. · 2006
- 4 generations backK070562 EZ Plus Implant SystemMegagen Co., Ltd. · 2007
- 3 generations backK073486 Dentis Dental Implant SystemDentis Co., Ltd. · 2008
- 2 generations backK160221 Implance Dental Implant System, Implance Dental Abutment SystemAgs Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti. · 2016
- 1 generation backK181266 Implantswiss Dental Implant System, Implantswiss Dental Abutment…Novodent SA · 2018
- This deviceK200867 Implantswiss Dental Implant System and Implantswiss Dental Abutment…Novodent SA · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K944964 | Branemark System Miruscone Abutment System | Nobelpharma USA, Inc. | 1995 | — |
| −10 | K961728 | Miruscone Abutment System | Nobelpharma USA, Inc. | 1996 | — |
| −9 | K962403 | Noblepharma Wide Accessories | Nobelpharma USA, Inc. | 1996 | — |
| −8 | K971706 | Tiadapt Abutment System | Nobel Biocare Uas, Inc. | 1997 | — |
| −7 | K974150 | Procera Preparable Abutment System | Nobel Biocare Uas, Inc. | 1998 | 2 |
| −6 | K041655 | Bio Plant System (Implants and Abutments) | Cowellmedi Co., Ltd. | 2004 | — |
| −5 | K052369 | Exfeel Implant System | Megagen Co., Ltd. | 2006 | — |
| −4 | K070562 | EZ Plus Implant System | Megagen Co., Ltd. | 2007 | — |
| −3 | K073486 | Dentis Dental Implant System | Dentis Co., Ltd. | 2008 | — |
| −2 | K160221 | Implance Dental Implant System, Implance Dental Abutment System | Ags Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti. | 2016 | — |
| −1 | K181266 | Implantswiss Dental Implant System, Implantswiss Dental Abutment System | Novodent SA | 2018 | — |
| 0 (this device) | K200867 | Implantswiss Dental Implant System and Implantswiss Dental Abutment System | Novodent SA | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 4 | 0 |
| 1992 | 1 | 0 |
| 1993 | 13 | 0 |
| 1994 | 11 | 0 |
| 1995 | 7 | 0 |
| 1996 | 8 | 0 |
| 1997 | 4 | 0 |
| 1998 | 4 | 0 |
| 1999 | 7 | 0 |
| 2000 | 5 | 0 |
| 2001 | 7 | 0 |
| 2002 | 15 | 0 |
| 2003 | 9 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 6 | 0 |
| 2007 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 4 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K181266 | Implantswiss Dental Implant System, Implantswiss Dental Abutment SystemSummary page 4…Subsequent Product Code NHA Regulation Number 21 CFR 872.3640 PREDICATE DEVICE Primary Predicate Device: K181266 - Implantswiss Dental Implant System Implantswiss Dental Abutment System… | 2018 |
| † | K160221 | Implance Dental Implant System, Implance Dental Abutment System | 2016 |
| † | K161416 | Multi-unit Abutment Plus | 2017 |
| † | K150295 | LOCATOR RTx | 2015 |
| † | K181037 | DIO CAD/CAM Abutment | 2018 |
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 25 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 14 of the 143 ancestors have a recall of any class.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
Implantswiss Dental Implant System is indicated to use for surgical placement in the upper and lower jaw arches, to provide a root form means for single and multiple units' prosthetic appliance attachment to restore a patient's chewing function. Implantswiss Dental Implant 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.…
Read the full statement (166 words)
Implantswiss Dental Implant System is indicated to use for surgical placement in the upper and lower jaw arches, to provide a root form means for single and multiple units' prosthetic appliance attachment to restore a patient's chewing function. Implantswiss Dental Implant 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.
Implantswiss Dental Abutment System is used with a dental implant to provide support to prosthetic restorations such as crown, bridge and overdentures in partially or fully edentulous patients. Octa and Multi-Unit Abutment models that contain an abutment post height less than 4 mm are indicated only for multi-unit loading, such as a bridge or overdenture. All digitally designed Premill abutments for use with the Implantswiss Dental Abutment System are intended to be sent to a Novodent validated milling center for manufacture.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200867 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200867: Implantswiss Dental Implant System and Implantswiss Dental Abutment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200867
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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