510(k) · Cleared
ClearedZ5C
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Z-Systems AG · DZE Implant, Endosseous, Root-Form
Cleared on Jul 3, 2014 as substantially equivalent to K120793 (Z-Systems AG, 2012) and 6 other predicates after a 293-day review. Its family tree reaches back 10 generations to 1995. 8 later devices descend from it.
- Decided
- Jul 3, 2014
- Review
- 293 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 10 generations to K944964 (1995). 85 ancestors in all, the oldest K871863 (1987). 8 later devices descend from it, 4 citing it directly.
- Root · 10 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 6 generations between
- 3 generations backK052070 Atlantis Abutment in Zirconia, Atlantis Gemini Abutment in Zirconia…Atlantis Components, Inc. · 2005
- 2 generations backK062277 Atlantis Abutment in Zirconia for Nobel Biocare ReplaceAtlantis Components, Inc. · 2006
- 1 generation backK091920 Atlantis Abutment in Zirconia, Atlantis Gemini Abutment for Nobel…Astra Tech, Inc. · 2009
- This deviceK132881 Z5CZ-Systems AG · 2014
- Descendant · cites it directly · 4 of its ownK172668 W Zirconia ImplantsTav Medical, Ltd. · 2018
- Descendant · cites it directly · 2 of its ownK190243 Z5-BLZ-Systems AG · 2020
- Descendant · 2 generations on · 1 of its ownK181953 SDS1.2 dental implantSds Swiss Dental Solutions AG · 2019
- Descendant · 2 generations on · 1 of its ownK192053 W Zirconia ImplantsTav Medical, Ltd. · 2019
- Descendant · 3 generations on · 0 of its ownK221488 Z7 Zirconia Implant SystemZ7, LLC · 2023
Show all 10 generations
- Root · 10 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 9 generations backK961728 Miruscone Abutment SystemNobelpharma USA, Inc. · 1996
- 8 generations backK962403 Noblepharma Wide AccessoriesNobelpharma USA, Inc. · 1996
- 7 generations backK971706 Tiadapt Abutment SystemNobel Biocare Uas, Inc. · 1997
- 6 generations backK974150 Procera Preparable Abutment SystemNobel Biocare Uas, Inc. · 1998 · Recalled
- 5 generations backK032263 3I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc. · 2004 · Recalled
- 4 generations backK042658 Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001…Nobel Biocare Uas, Inc. · 2004
- 3 generations backK052070 Atlantis Abutment in Zirconia, Atlantis Gemini Abutment in Zirconia…Atlantis Components, Inc. · 2005
- 2 generations backK062277 Atlantis Abutment in Zirconia for Nobel Biocare ReplaceAtlantis Components, Inc. · 2006
- 1 generation backK091920 Atlantis Abutment in Zirconia, Atlantis Gemini Abutment for Nobel…Astra Tech, Inc. · 2009
- This deviceK132881 Z5CZ-Systems AG · 2014
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K172668W Zirconia ImplantsTav Medical, Ltd. · 2018 · cites it directly4descendants
- K190243Z5-BLZ-Systems AG · 2020 · cites it directly2descendants
- K181953SDS1.2 dental implantSds Swiss Dental Solutions AG · 2019 · 2 generations on1descendant
- K192053W Zirconia ImplantsTav Medical, Ltd. · 2019 · 2 generations on1descendant
- K221488Z7 Zirconia Implant SystemZ7, LLC · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K944964 | Branemark System Miruscone Abutment System | Nobelpharma USA, Inc. | 1995 | — |
| −9 | K961728 | Miruscone Abutment System | Nobelpharma USA, Inc. | 1996 | — |
| −8 | K962403 | Noblepharma Wide Accessories | Nobelpharma USA, Inc. | 1996 | — |
| −7 | K971706 | Tiadapt Abutment System | Nobel Biocare Uas, Inc. | 1997 | — |
| −6 | K974150 | Procera Preparable Abutment System | Nobel Biocare Uas, Inc. | 1998 | 2 |
| −5 | K032263 | 3I Patient-Specific Dental Abutment and Overdenture Bar | Implant Innovations, Inc. | 2004 | 1 |
| −4 | K042658 | Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004… | Nobel Biocare Uas, Inc. | 2004 | — |
| −3 | K052070 | Atlantis Abutment in Zirconia, Atlantis Gemini Abutment in Zirconia, Atlantis… | Atlantis Components, Inc. | 2005 | — |
| −2 | K062277 | Atlantis Abutment in Zirconia for Nobel Biocare Replace | Atlantis Components, Inc. | 2006 | — |
| −1 | K091920 | Atlantis Abutment in Zirconia, Atlantis Gemini Abutment for Nobel Replace… | Astra Tech, Inc. | 2009 | — |
| 0 (this device) | K132881 | Z5C | Z-Systems AG | 2014 | — |
| +1 | K172668 | W Zirconia Implants | Tav Medical, Ltd. | 2018 | — |
| +1 | K190243 | Z5-BL | Z-Systems AG | 2020 | — |
| +2 | K181953 | SDS1.2 dental implant | Sds Swiss Dental Solutions AG | 2019 | — |
| +2 | K192053 | W Zirconia Implants | Tav Medical, Ltd. | 2019 | — |
| +3 | K221488 | Z7 Zirconia Implant System | Z7, LLC | 2023 | — |
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 |
| 1993 | 10 | 0 |
| 1994 | 9 | 0 |
| 1995 | 6 | 0 |
| 1996 | 7 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 4 | 0 |
| 2000 | 3 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 4 | 0 |
| 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? (7)
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 |
|---|---|---|---|
| * | K120793 | Z-LOOK3 Evo SLMSummary page 2…medical devices, Z5c is substantially equivalent in indications and design principles to the following legally marketed predicate devices: Z-Systems AG; Z-Look3 Evo SLM, K 120793; Nobel Biocare USA Inc., Nobel Biocare Endosseous Implants, K04 166 1; Nobel Biocare AR, Nobel Procera Zi Abutment, K091904; Astr… | 2012 |
| * | K041661 | Nobel Biocare Endosseous ImplantsSummary page 2…esign principles to the following legally marketed predicate devices: Z-Systems AG; Z-Look3 Evo SLM, K 120793; Nobel Biocare USA Inc., Nobel Biocare Endosseous Implants, K04 166 1; Nobel Biocare AR, Nobel Procera Zi Abutment, K091904; Astra Tech Inc., AtlantiSTM Abutment in Zirconia for Nobel Replace Implant… | 2004 |
| * | K091904 | Nobelprocera ZI AbutmentSummary page 2…cate devices: Z-Systems AG; Z-Look3 Evo SLM, K 120793; Nobel Biocare USA Inc., Nobel Biocare Endosseous Implants, K04 166 1; Nobel Biocare AR, Nobel Procera Zi Abutment, K091904; Astra Tech Inc., AtlantiSTM Abutment in Zirconia for Nobel Replace Implant, K091920; Atlantis Components Inc., AtlantiSTM Abutme… | 2009 |
| * | K091920 | Atlantis Abutment in Zirconia, Atlantis Gemini Abutment for Nobel Replace Implants…Summary page 2…Biocare Endosseous Implants, K04 166 1; Nobel Biocare AR, Nobel Procera Zi Abutment, K091904; Astra Tech Inc., AtlantiSTM Abutment in Zirconia for Nobel Replace Implant, K091920; Atlantis Components Inc., AtlantiSTM Abutment in Zirconia for Nobel Biocare Replace, K062277; Altatec GmnbH, Camlog Implant Syst… | 2009 |
| * | K062277 | Atlantis Abutment in Zirconia for Nobel Biocare ReplaceSummary page 2…Astra Tech Inc., AtlantiSTM Abutment in Zirconia for Nobel Replace Implant, K091920; Atlantis Components Inc., AtlantiSTM Abutment in Zirconia for Nobel Biocare Replace, K062277; Altatec GmnbH, Camlog Implant System Modified Implants and Abutments, K083496; and Astra Tech Inc., AtlantiSTM Abutment for Caml… | 2006 |
| * | K083496 | Camlog Implant System Modified Implants and AbutmentsSummary page 2…1920; Atlantis Components Inc., AtlantiSTM Abutment in Zirconia for Nobel Biocare Replace, K062277; Altatec GmnbH, Camlog Implant System Modified Implants and Abutments, K083496; and Astra Tech Inc., AtlantiSTM Abutment for Camlog Implant, K 110640. The subject device and thepredicate devices have the sam… | 2009 |
| * | K110640 | Atlantis Abutment for Camlog Implant, Duplicate Abutment, Later AbutmentSummary page 2…bel Biocare Replace, K062277; Altatec GmnbH, Camlog Implant System Modified Implants and Abutments, K083496; and Astra Tech Inc., AtlantiSTM Abutment for Camlog Implant, K 110640. The subject device and thepredicate devices have the same intended use and have the same technological characteristics. The sub… | 2011 |
What descends from it? (8)
4 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 19 years and passes through 6 companies; a new generation was cleared every 1.2 years on median.
- 8 of the 85 ancestors have a recall of any class.
- Of its descendants, K172668 (Tav Medical, Ltd., 2018) has gone furthest, with 4 descendants of its own.
- 4 other devices also cite its predicate K120793.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
Z5c implants are designed for surgical implantation into the upper and lower jaw for the attachment of prosthodontic appliances to replace missing teeth. Z5c implant system is also suitable for patients with metal allergies and the chronic diseases resulting from them. Z5c implants are intended for delayed loading.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132881 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132881: Z5C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132881
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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