510(k) · Cleared
ClearedMulti-Unit DAS System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Talladium España, SL · NHA Abutment, Implant, Dental, Endosseous
Cleared on Nov 17, 2023 as substantially equivalent to K221966 (Talladium Espana, SL, 2022) after a 171-day review. Its family tree reaches back 21 generations to 1996. 1 later device descends from it.
- Decided
- Nov 17, 2023
- Review
- 171 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 21 generations to K960026 (1996). 325 ancestors in all, the oldest K781060 (1978). 1 later device descends from it, 1 citing it directly.
- Root · 21 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 17 generations between
- 3 generations backK202026 Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC · 2020
- 2 generations backK212108 Dynamic TiBaseTalladium España, SL · 2021
- 1 generation backK221966 Dynamic TiBaseTalladium Espana, SL · 2022
- This deviceK231559 Multi-Unit DAS SystemTalladium España, SL · 2023
- Descendant · cites it directly · 0 of its ownK243732 Multi-Unit DAS SystemTalladium España, SL · 2026
Show all 21 generations
- Root · 21 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 20 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 19 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 18 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 17 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 16 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 15 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 14 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 13 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 12 generations backK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
- 11 generations backK081653 Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · Recalled
- 10 generations backK123022 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013
- 9 generations backK133510 Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014
- 8 generations backK133592 Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua…Neodent USA, Inc. · 2014
- 7 generations backK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
- 6 generations backK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- 5 generations backK173908 DESS Dental Smart SolutionsTerrats Medical SL · 2018
- 4 generations backK191986 DESS Dental Smart SolutionsTerrats Medical SL · 2019
- 3 generations backK202026 Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC · 2020
- 2 generations backK212108 Dynamic TiBaseTalladium España, SL · 2021
- 1 generation backK221966 Dynamic TiBaseTalladium Espana, SL · 2022
- This deviceK231559 Multi-Unit DAS SystemTalladium España, SL · 2023
Most influential descendants
Showing 1 of 1 · See all- K243732Multi-Unit DAS SystemTalladium España, SL · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −20 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −19 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −18 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −17 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −16 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −15 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −14 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −13 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −12 | K063364 | Alpha Bio Dental Implant System | Alpha-Bio Tec, Ltd. | 2007 | — |
| −11 | K081653 | Mdi Mii One-Piece Implant, 2.9MM | Imtec Corp. | 2008 | 1 |
| −10 | K123022 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2013 | — |
| −9 | K133510 | Neodent Implant System | Jj Industria E Comercio DE Materiais Dentarios SA | 2014 | — |
| −8 | K133592 | Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart… | Neodent USA, Inc. | 2014 | — |
| −7 | K150367 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2015 | — |
| −6 | K170588 | DESS Dental Smart Solutions | Terrats Medical SL | 2017 | — |
| −5 | K173908 | DESS Dental Smart Solutions | Terrats Medical SL | 2018 | — |
| −4 | K191986 | DESS Dental Smart Solutions | Terrats Medical SL | 2019 | — |
| −3 | K202026 | Blue Sky Bio CAD-CAM Abutments | Blue Sky Bio, LLC | 2020 | — |
| −2 | K212108 | Dynamic TiBase | Talladium España, SL | 2021 | — |
| −1 | K221966 | Dynamic TiBase | Talladium Espana, SL | 2022 | — |
| 0 (this device) | K231559 | Multi-Unit DAS System | Talladium España, SL | 2023 | — |
| +1 | K243732 | Multi-Unit DAS System | Talladium España, SL | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 5 | 0 |
| 1990 | 7 | 0 |
| 1991 | 1 | 0 |
| 1992 | 4 | 0 |
| 1993 | 12 | 0 |
| 1994 | 12 | 0 |
| 1995 | 15 | 0 |
| 1996 | 16 | 0 |
| 1997 | 7 | 0 |
| 1998 | 8 | 0 |
| 1999 | 11 | 0 |
| 2000 | 11 | 0 |
| 2001 | 18 | 0 |
| 2002 | 19 | 0 |
| 2003 | 17 | 0 |
| 2004 | 16 | 0 |
| 2005 | 14 | 0 |
| 2006 | 17 | 0 |
| 2007 | 24 | 0 |
| 2008 | 14 | 0 |
| 2009 | 13 | 0 |
| 2010 | 10 | 0 |
| 2011 | 10 | 0 |
| 2012 | 5 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 NHA? 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 NHA device
- #1 K222288 DESS Dental Smart Solutionsscore 30.6 · 19 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 |
|---|---|---|---|
| * | K221966 | Dynamic TiBaseSummary page 5…almic, Anesthesia, Respiratory, ENT and Dental Devices) Reviewing Division Division of Dental and ENT Devices PREDICATE DEVICE INFORMATION Primary Predicate Device K221966, Dynamic TiBase, Talladium España, SL Reference Devices K230143, DESS® Dental Smart Solutions, Terrats Medical SL K220200, Palto… | 2022 |
| † | K230143 | DESS Dental Smart Solutions | 2023 |
| † | K220200 | Paltop Conical Implant System | 2022 |
| † | K101732 | Astra Tech Implant System | 2011 |
| † | K063341 | 3I Osseotite Certain Dental Implants | 2007 |
| † | K140091 | Xpeed Anyridge Internal Implant Sysyem | 2014 |
| † | K110955 | Anyridge Internal Implant System | 2011 |
| † | K142260 | NobelActive | 2015 |
| † | K013227 | Screw Vent Implant; Tapered Screw Vent Implant | 2001 |
| † | K072589 | Tapered Screw-Vent Implant, 4.1MM, Models: TSV4B8, B10, B11, B13 and B16, TSV4H8, H11… | 2007 |
| † | K120243 | GAM-200 | 2012 |
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 |
|---|---|---|---|
| K243732 | Multi-Unit DAS System | 2026 | 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 27 years and passes through 10 companies; a new generation was cleared every 10 months on median.
- 44 of the 325 ancestors have a recall of any class.
- Of its descendants, K243732 (Talladium España, SL, 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K221966.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · NHA
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NHA
147in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NHA
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NHA
838in 2025
MAUDE reports naming product code NHA, 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 | 38 | 91 | 1 | 1 |
| 2008 | 31 | 90 | 2 | 8 |
| 2009 | 30 | 95 | 0 | 30 |
| 2010 | 19 | 162 | 0 | 61 |
| 2011 | 31 | 130 | 5 | 56 |
| 2012 | 25 | 171 | 1 | 5 |
| 2013 | 22 | 184 | 1 | 143 |
| 2014 | 27 | 160 | 0 | 146 |
| 2015 | 29 | 151 | 1 | 858 |
| 2016 | 38 | 202 | 36 | 314 |
| 2017 | 31 | 188 | 2 | 577 |
| 2018 | 31 | 200 | 1 | 591 |
| 2019 | 28 | 160 | 0 | 530 |
| 2020 | 38 | 153 | 7 | 458 |
| 2021 | 29 | 211 | 0 | 546 |
| 2022 | 33 | 142 | 0 | 497 |
| 2023 | 51 | 147 | 3 | 618 |
| 2024 | 43 | 158 | 0 | 635 |
| 2025 | 40 | 147 | 1 | 838 |
| 2026 | 23 | 169 | 3 | — |
What is it indicated for?
Multi-Unit DAS System abutments are intended for use with dental implants as a support for single-unit or multi-unit prostheses in the maxillary or mandibular arch of a partially or fully edentulous patient. Compatible Implant Systems Astra Tech OsseoSpeed TX: implant body diameter 3.5 mm, implant platform 3.5/4.0 mm; implant body diameter 4.0 mm, implant platform 3.5/4.0 mm. Biomet 3i OSSEOTITE® Certain®: implant body diameter 3.25 mm, implant platform…
Read the full statement (153 words)
Multi-Unit DAS System abutments are intended for use with dental implants as a support for single-unit or multi-unit prostheses in the maxillary or mandibular arch of a partially or fully edentulous patient.
Compatible Implant Systems
Astra Tech OsseoSpeed TX: implant body diameter 3.5 mm, implant platform 3.5/4.0 mm; implant body diameter 4.0 mm, implant platform 3.5/4.0 mm.
Biomet 3i OSSEOTITE® Certain®: implant body diameter 3.25 mm, implant platform 3.4 mm; implant body diameter 4.0 mm, implant platform 4.1 mm.
MegaGen AnyRidge: implant body diameter 3.5, 4.0, 4.4, 4.9, 5.4 mm; implant platform 3.5 mm.
NobelActive®: implant body diameter 3.5 mm, implant platform 3.5 (NP) mm; implant body diameter 4.3, 5.0 mm, implant platform 3.9 (RP) mm.
Zimmer Tapered Screw-Vent®: implant body diameter 3.7, 4.1 mm, implant platform 3.5 mm.
All digitally designed custom abutments for use with Multi-Unit DAS System abutments are to be sent to a Talladium validated milling center for manufacture.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231559 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231559: Multi-Unit DAS System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231559
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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