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 Oct 14, 2020 as substantially equivalent to K190243 (Z-Systems AG, 2020) and 3 other predicates after a 239-day review. Its family tree reaches back 12 generations to 1996.
- Decided
- Oct 14, 2020
- Review
- 239 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 12 generations to K960026 (1996). 161 ancestors in all, the oldest K871863 (1987). No later device cites it as a predicate yet.
- Root · 12 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 8 generations between
- 3 generations backK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
- 2 generations backK081653 Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · Recalled
- 1 generation backK131701 Z5MLB, Z5MLCZ-Systems AG · 2013
- This deviceK200386 Z5-BLZ-Systems AG · 2020
Show all 12 generations
- Root · 12 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 11 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 10 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 9 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 8 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 7 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 6 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 5 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 4 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 3 generations backK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
- 2 generations backK081653 Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · Recalled
- 1 generation backK131701 Z5MLB, Z5MLCZ-Systems AG · 2013
- This deviceK200386 Z5-BLZ-Systems AG · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −11 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −10 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −9 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −8 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −7 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −6 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −5 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −4 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −3 | K063364 | Alpha Bio Dental Implant System | Alpha-Bio Tec, Ltd. | 2007 | — |
| −2 | K081653 | Mdi Mii One-Piece Implant, 2.9MM | Imtec Corp. | 2008 | 1 |
| −1 | K131701 | Z5MLB, Z5MLC | Z-Systems AG | 2013 | — |
| 0 (this device) | K200386 | Z5-BL | Z-Systems AG | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 3 | 0 |
| 1991 | 1 | 0 |
| 1993 | 11 | 0 |
| 1994 | 10 | 0 |
| 1995 | 10 | 0 |
| 1996 | 13 | 0 |
| 1997 | 5 | 0 |
| 1998 | 5 | 0 |
| 1999 | 9 | 0 |
| 2000 | 9 | 0 |
| 2001 | 11 | 0 |
| 2002 | 14 | 0 |
| 2003 | 12 | 0 |
| 2004 | 9 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 4 | 0 |
| 2008 | 1 | 0 |
| 2009 | 6 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2020 | 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? (4)
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 |
|---|---|---|---|
| * | K190243 | Z5-BLSummary page 4…ENT and Dental Devices) Reviewing Division Division of Health Technology 1 B (Dental Devices) PREDICATE DEVICE INFORMATION Primary Predicate Device: K190243, Z5-BL, Z-Systems AG Reference Devices: K132881, Z5c, Z-Systems AG K131701, Z5mlb and Z5mlc, Z-Systems AG K120793, Z-Look3 Evo SL… | 2020 |
| * | K132881 | Z5CSummary page 4…ision Division of Health Technology 1 B (Dental Devices) PREDICATE DEVICE INFORMATION Primary Predicate Device: K190243, Z5-BL, Z-Systems AG Reference Devices: K132881, Z5c, Z-Systems AG K131701, Z5mlb and Z5mlc, Z-Systems AG K120793, Z-Look3 Evo SLM, Z-Systems AG… | 2014 |
| * | K131701 | Z5MLB, Z5MLCSummary page 4…Health Technology 1 B (Dental Devices) PREDICATE DEVICE INFORMATION Primary Predicate Device: K190243, Z5-BL, Z-Systems AG Reference Devices: K132881, Z5c, Z-Systems AG K131701, Z5mlb and Z5mlc, Z-Systems AG K120793, Z-Look3 Evo SLM, Z-Systems AG… | 2013 |
| * | K120793 | Z-LOOK3 Evo SLMSummary page 4…PREDICATE DEVICE INFORMATION Primary Predicate Device: K190243, Z5-BL, Z-Systems AG Reference Devices: K132881, Z5c, Z-Systems AG K131701, Z5mlb and Z5mlc, Z-Systems AG K120793, Z-Look3 Evo SLM, Z-Systems AG Page… | 2012 |
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 24 years and passes through 4 companies; a new generation was cleared every 10 months on median.
- 19 of the 161 ancestors have a recall of any class.
- 1 other device also cites its predicate K190243.
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/K200386 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200386: Z5-BL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200386
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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