510(k) · Cleared
ClearedSDS2.2 dental implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sds Swiss Dental Solutions AG · DZE Implant, Endosseous, Root-Form
Cleared on Feb 20, 2020 as substantially equivalent to K181953 (Sds Swiss Dental Solutions AG, 2019) after a 364-day review. Its family tree reaches back 13 generations to 1995.
- Decided
- Feb 20, 2020
- Review
- 364 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K944964 (1995). 93 ancestors in all, the oldest K871863 (1987). No later device cites it as a predicate yet.
- Root · 13 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 9 generations between
- 3 generations backK132881 Z5CZ-Systems AG · 2014
- 2 generations backK172668 W Zirconia ImplantsTav Medical, Ltd. · 2018
- 1 generation backK181953 SDS1.2 dental implantSds Swiss Dental Solutions AG · 2019
- This deviceK190406 SDS2.2 dental implantSds Swiss Dental Solutions AG · 2020
Show all 13 generations
- Root · 13 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 12 generations backK961728 Miruscone Abutment SystemNobelpharma USA, Inc. · 1996
- 11 generations backK962403 Noblepharma Wide AccessoriesNobelpharma USA, Inc. · 1996
- 10 generations backK971706 Tiadapt Abutment SystemNobel Biocare Uas, Inc. · 1997
- 9 generations backK974150 Procera Preparable Abutment SystemNobel Biocare Uas, Inc. · 1998 · Recalled
- 8 generations backK032263 3I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc. · 2004 · Recalled
- 7 generations backK042658 Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001…Nobel Biocare Uas, Inc. · 2004
- 6 generations backK052070 Atlantis Abutment in Zirconia, Atlantis Gemini Abutment in Zirconia…Atlantis Components, Inc. · 2005
- 5 generations backK062277 Atlantis Abutment in Zirconia for Nobel Biocare ReplaceAtlantis Components, Inc. · 2006
- 4 generations backK091920 Atlantis Abutment in Zirconia, Atlantis Gemini Abutment for Nobel…Astra Tech, Inc. · 2009
- 3 generations backK132881 Z5CZ-Systems AG · 2014
- 2 generations backK172668 W Zirconia ImplantsTav Medical, Ltd. · 2018
- 1 generation backK181953 SDS1.2 dental implantSds Swiss Dental Solutions AG · 2019
- This deviceK190406 SDS2.2 dental implantSds Swiss Dental Solutions AG · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K944964 | Branemark System Miruscone Abutment System | Nobelpharma USA, Inc. | 1995 | — |
| −12 | K961728 | Miruscone Abutment System | Nobelpharma USA, Inc. | 1996 | — |
| −11 | K962403 | Noblepharma Wide Accessories | Nobelpharma USA, Inc. | 1996 | — |
| −10 | K971706 | Tiadapt Abutment System | Nobel Biocare Uas, Inc. | 1997 | — |
| −9 | K974150 | Procera Preparable Abutment System | Nobel Biocare Uas, Inc. | 1998 | 2 |
| −8 | K032263 | 3I Patient-Specific Dental Abutment and Overdenture Bar | Implant Innovations, Inc. | 2004 | 1 |
| −7 | K042658 | Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004… | Nobel Biocare Uas, Inc. | 2004 | — |
| −6 | K052070 | Atlantis Abutment in Zirconia, Atlantis Gemini Abutment in Zirconia, Atlantis… | Atlantis Components, Inc. | 2005 | — |
| −5 | K062277 | Atlantis Abutment in Zirconia for Nobel Biocare Replace | Atlantis Components, Inc. | 2006 | — |
| −4 | K091920 | Atlantis Abutment in Zirconia, Atlantis Gemini Abutment for Nobel Replace… | Astra Tech, Inc. | 2009 | — |
| −3 | K132881 | Z5C | Z-Systems AG | 2014 | — |
| −2 | K172668 | W Zirconia Implants | Tav Medical, Ltd. | 2018 | — |
| −1 | K181953 | SDS1.2 dental implant | Sds Swiss Dental Solutions AG | 2019 | — |
| 0 (this device) | K190406 | SDS2.2 dental implant | Sds Swiss Dental Solutions AG | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 10 | 0 |
| 1994 | 9 | 0 |
| 1995 | 7 | 0 |
| 1996 | 8 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 4 | 0 |
| 2000 | 4 | 0 |
| 2001 | 4 | 0 |
| 2002 | 6 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2007 | 2 | 0 |
| 2009 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2016 | 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 |
|---|---|---|---|
| * | K181953 | SDS1.2 dental implant Cleared while this submission was under review Summary page 4…device SDS2.2 dental implant Device Owner/ 510(k) # Product Code Trade Name Primary SDS Swiss Dental K181953 DZE (Implant, Endosseous, Predicate Solutions AG/ SDS1.2 Root-Form) Device dental i… | 2019 |
| † | K172668 | W Zirconia Implants | 2018 |
| † | K132881 | Z5C | 2014 |
| † | K163043 | Zeramex P6 Dental Implant System | 2016 |
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 8 companies; a new generation was cleared every 1.0 years on median.
- 8 of the 93 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?
SDS2.2 dental implants are intended as artificial replacements to be placed in the human upper or lower jaw to provide anchor points for the prosthetic restoration. They are indicated for transgingival healing. The implants are indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
SDS2.2 standard implant posts and SDS2.2 standard screws are industrially manufactured prosthetic components. They are connected to the SDS2.2 dental implant and enable the fixation of prosthetic restorations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190406 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190406: SDS2.2 dental implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190406
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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