510(k) · Cleared
ClearedZ5-BL
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 Jan 3, 2020 as substantially equivalent to K132881 (Z-Systems AG, 2014) after a 331-day review. Its family tree reaches back 11 generations to 1995. 2 later devices descend from it.
- Decided
- Jan 3, 2020
- Review
- 331 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K944964 (1995). 86 ancestors in all, the oldest K871863 (1987). 2 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
- 7 generations between
- 3 generations backK062277 Atlantis Abutment in Zirconia for Nobel Biocare ReplaceAtlantis Components, Inc. · 2006
- 2 generations backK091920 Atlantis Abutment in Zirconia, Atlantis Gemini Abutment for Nobel…Astra Tech, Inc. · 2009
- 1 generation backK132881 Z5CZ-Systems AG · 2014
- This deviceK190243 Z5-BLZ-Systems AG · 2020
- Descendant · cites it directly · 0 of its ownK201712 Z5-TLZ-Systems AG · 2020
- Descendant · cites it directly · 0 of its ownK200386 Z5-BLZ-Systems AG · 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 backK032263 3I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc. · 2004 · Recalled
- 5 generations backK042658 Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001…Nobel Biocare Uas, Inc. · 2004
- 4 generations backK052070 Atlantis Abutment in Zirconia, Atlantis Gemini Abutment in Zirconia…Atlantis Components, Inc. · 2005
- 3 generations backK062277 Atlantis Abutment in Zirconia for Nobel Biocare ReplaceAtlantis Components, Inc. · 2006
- 2 generations backK091920 Atlantis Abutment in Zirconia, Atlantis Gemini Abutment for Nobel…Astra Tech, Inc. · 2009
- 1 generation backK132881 Z5CZ-Systems AG · 2014
- This deviceK190243 Z5-BLZ-Systems AG · 2020
Most influential descendants
Showing 2 of 2 · See allView 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 | K032263 | 3I Patient-Specific Dental Abutment and Overdenture Bar | Implant Innovations, Inc. | 2004 | 1 |
| −5 | K042658 | Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004… | Nobel Biocare Uas, Inc. | 2004 | — |
| −4 | K052070 | Atlantis Abutment in Zirconia, Atlantis Gemini Abutment in Zirconia, Atlantis… | Atlantis Components, Inc. | 2005 | — |
| −3 | K062277 | Atlantis Abutment in Zirconia for Nobel Biocare Replace | Atlantis Components, Inc. | 2006 | — |
| −2 | K091920 | Atlantis Abutment in Zirconia, Atlantis Gemini Abutment for Nobel Replace… | Astra Tech, Inc. | 2009 | — |
| −1 | K132881 | Z5C | Z-Systems AG | 2014 | — |
| 0 (this device) | K190243 | Z5-BL | Z-Systems AG | 2020 | — |
| +1 | K201712 | Z5-TL | Z-Systems AG | 2020 | — |
| +1 | K200386 | Z5-BL | Z-Systems 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 |
| 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 |
|---|---|---|
| 2020 | 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 |
|---|---|---|---|
| * | K132881 | Z5CSummary page 4…Classification Panel Dental Products Panel Reviewing Branch Dental Devices Branch PREDICATE DEVICE INFORMATION Primary Predicate Device: K132881, Z5c, Z-Systems AG Reference Devices: K131701, Z5mlb and Z5mlc, Z-Systems AG K153509, GPS® Angled Abutment, Implant Direct Sybro… | 2014 |
| † | K131701 | Z5MLB, Z5MLC | 2013 |
| † | K153509 | GPS Angled Abutment | 2016 |
| † | K121131 | BL, 04.1 MM RC, Slactive 8MM, Tizr and 10MM, 12, 14MM | 2012 |
| † | K172668 | W Zirconia Implants | 2018 |
| † | K063286 | Osseotite; Osseotite NT; XP; TG Osseotite | 2007 |
| † | K072642 | Biomet 3I Dental Abutments and Restorative Components | 2007 |
What descends from it? (2)
2 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 25 years and passes through 6 companies; a new generation was cleared every 1.2 years on median.
- 8 of the 86 ancestors have a recall of any class.
- Of its descendants, K201712 (Z-Systems AG, 2020) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K132881.
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?
Z5-BL implants are designed for surgical implantation into the upper and lower jaw for the attachment of prosthodontic appliances to replace missing teeth. Z5-BL implants are suitable for patients with metal allergies and the chronic diseases resulting from them. Z5-BL implants are intended for delayed loading.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190243 · printed Nov 3, 2026
Cite this page
510(k) Report. “K190243: Z5-BL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K190243
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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