510(k) · Cleared
ClearedZ5MLB, Z5MLC
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 Sep 5, 2013 as substantially equivalent to K120793 (Z-Systems AG, 2012) and 7 other predicates after an 86-day review. Its family tree reaches back 11 generations to 1996. 1 later device descends from it.
- Decided
- Sep 5, 2013
- Review
- 86 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 11 generations to K960026 (1996). 100 ancestors in all, the oldest K874590 (1988). 1 later device descends from it, 1 citing it directly.
- Root · 11 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 7 generations between
- 3 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 2 generations backK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
- 1 generation backK081653 Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · Recalled
- This deviceK131701 Z5MLB, Z5MLCZ-Systems AG · 2013
- Descendant · cites it directly · 0 of its ownK200386 Z5-BLZ-Systems AG · 2020
Show all 11 generations
- Root · 11 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 10 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 9 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 8 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 7 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 6 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 5 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 4 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 3 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 2 generations backK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
- 1 generation backK081653 Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · Recalled
- This deviceK131701 Z5MLB, Z5MLCZ-Systems AG · 2013
Most influential descendants
Showing 1 of 1 · See all- K200386Z5-BLZ-Systems AG · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −10 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −9 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −8 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −7 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −6 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −5 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −4 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −3 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −2 | K063364 | Alpha Bio Dental Implant System | Alpha-Bio Tec, Ltd. | 2007 | — |
| −1 | K081653 | Mdi Mii One-Piece Implant, 2.9MM | Imtec Corp. | 2008 | 1 |
| 0 (this device) | K131701 | Z5MLB, Z5MLC | Z-Systems AG | 2013 | — |
| +1 | K200386 | Z5-BL | Z-Systems AG | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 4 | 0 |
| 1996 | 8 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 7 | 0 |
| 2000 | 7 | 0 |
| 2001 | 10 | 0 |
| 2002 | 9 | 0 |
| 2003 | 10 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 4 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (8)
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…ts with metal allergies and the chronic diseases resulting from them. DEVICE DESCRIPTION The purpose of this submission is to expand the Z-Look3 Evo SLM implant line (K 120793) to include two implant designs indicated for denture attachment. The Z 5mlb and Z5mlc are one- piece, root-form, threaded implan… | 2012 |
| * | K062542 | Z-LOOK3 Dental Implant System, Model Z3-XXXSummary page 2…ications and design principles to the following legally marketed predicate devices: Z-Systems AG. Z-Look3 Evo SLM. K 120793; Z-Systems AG, Z-Look3 Dental Implant System, K062542; Oral Iceberg S.L., CeraRoot Implant System, K093595; IMTEC Corp., MDI MII 2.9 Implants, K08 1653; IMTEC Corp., IMTEC Sendlax MDI… | 2007 |
| * | K093595 | Ceraroot Implant SystemSummary page 2…ly marketed predicate devices: Z-Systems AG. Z-Look3 Evo SLM. K 120793; Z-Systems AG, Z-Look3 Dental Implant System, K062542; Oral Iceberg S.L., CeraRoot Implant System, K093595; IMTEC Corp., MDI MII 2.9 Implants, K08 1653; IMTEC Corp., IMTEC Sendlax MDI and MDI Plus, K031 106; Intra-Lock International, In… | 2011 |
| * | K081653 | Mdi Mii One-Piece Implant, 2.9MMSummary page 2…Z-Look3 Evo SLM. K 120793; Z-Systems AG, Z-Look3 Dental Implant System, K062542; Oral Iceberg S.L., CeraRoot Implant System, K093595; IMTEC Corp., MDI MII 2.9 Implants, K08 1653; IMTEC Corp., IMTEC Sendlax MDI and MDI Plus, K031 106; Intra-Lock International, Inc., MILOTM Dental Implant System, K050970; Im… | 2008 |
| * | K031106 | Imtec Sendax Mdi and Mdi Plus Endosseous Implant, Models OB-XX, SH-XX, Mob-22, MSH-XXSummary page 2…l Implant System, K062542; Oral Iceberg S.L., CeraRoot Implant System, K093595; IMTEC Corp., MDI MII 2.9 Implants, K08 1653; IMTEC Corp., IMTEC Sendlax MDI and MDI Plus, K031 106; Intra-Lock International, Inc., MILOTM Dental Implant System, K050970; Implant Direct, Spectra Dental Implant System K0613 19; a… | 2003 |
| * | K050970 | Milo Dental Implant SystemSummary page 2…093595; IMTEC Corp., MDI MII 2.9 Implants, K08 1653; IMTEC Corp., IMTEC Sendlax MDI and MDI Plus, K031 106; Intra-Lock International, Inc., MILOTM Dental Implant System, K050970; Implant Direct, Spectra Dental Implant System K0613 19; and Ace Surgical Supply Co., Inc., Ace Surgical SecureTm Locator® 3.25 m… | 2005 |
| * | K061319 | Spectra SystemSummary page 2…TEC Corp., IMTEC Sendlax MDI and MDI Plus, K031 106; Intra-Lock International, Inc., MILOTM Dental Implant System, K050970; Implant Direct, Spectra Dental Implant System K0613 19; and Ace Surgical Supply Co., Inc., Ace Surgical SecureTm Locator® 3.25 mm Implant System, K0935 18. The subject device and the… | 2006 |
| * | K093518 | Ace Surgical Secure Locator 3.25 Implant SystemSummary page 2…mplant System, K050970; Implant Direct, Spectra Dental Implant System K0613 19; and Ace Surgical Supply Co., Inc., Ace Surgical SecureTm Locator® 3.25 mm Implant System, K0935 18. The subject device and the predicate devices have the same intended use and have the same technological characteristics. The su… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200386 | Z5-BL | 2020 | 0 |
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 17 years and passes through 4 companies; a new generation was cleared every 9 months on median.
- 13 of the 100 ancestors have a recall of any class.
- Of its descendants, K200386 (Z-Systems AG, 2020) has gone furthest, with 0 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. 2013, 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?
Zsmlb implants arc designed for surgical implantation into the edentulous upper and lower jaw
for the attachment of dentures to replace missing teeth. Zsmlb implant system is also suitable for
patients with metal allergies and the chronic diseases resulting from them.
Zsmlc implants are designed for surgical implantation into the edentulous upper and lower jaw
for the attachment of dentures to replace missing teeth. Z5mlc implant system is also suitable for
patients with metal allergies and the chronic diseases resulting from them.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131701 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131701: Z5MLB, Z5MLC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131701
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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