510(k) · Cleared
ClearedICX-Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medentis Medical GmbH · DZE Implant, Endosseous, Root-Form
Cleared on Sep 5, 2024 as substantially equivalent to K130222 (Straumann USA, LLC, 2013) and 14 other predicates after a 463-day review. Its family tree reaches back 20 generations to 1996.
- Decided
- Sep 5, 2024
- Review
- 463 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 15
Its longest line of descent runs back 20 generations to K960026 (1996). 429 ancestors in all, the oldest K781060 (1978). No later device cites it as a predicate yet.
- Root · 20 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 16 generations between
- 3 generations backK191986 DESS Dental Smart SolutionsTerrats Medical SL · 2019
- 2 generations backK202026 Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC · 2020
- 1 generation backK212108 Dynamic TiBaseTalladium España, SL · 2021
- This deviceK231566 ICX-Implant SystemMedentis Medical GmbH · 2024
Show all 20 generations
- Root · 20 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 19 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 18 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 17 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 16 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 15 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 14 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 13 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 12 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 11 generations backK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
- 10 generations backK081653 Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · Recalled
- 9 generations backK123022 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013
- 8 generations backK133510 Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014
- 7 generations backK133592 Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua…Neodent USA, Inc. · 2014
- 6 generations backK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
- 5 generations backK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- 4 generations backK173908 DESS Dental Smart SolutionsTerrats Medical SL · 2018
- 3 generations backK191986 DESS Dental Smart SolutionsTerrats Medical SL · 2019
- 2 generations backK202026 Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC · 2020
- 1 generation backK212108 Dynamic TiBaseTalladium España, SL · 2021
- This deviceK231566 ICX-Implant SystemMedentis Medical GmbH · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −19 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −18 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −17 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −16 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −15 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −14 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −13 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −12 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −11 | K063364 | Alpha Bio Dental Implant System | Alpha-Bio Tec, Ltd. | 2007 | — |
| −10 | K081653 | Mdi Mii One-Piece Implant, 2.9MM | Imtec Corp. | 2008 | 1 |
| −9 | K123022 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2013 | — |
| −8 | K133510 | Neodent Implant System | Jj Industria E Comercio DE Materiais Dentarios SA | 2014 | — |
| −7 | K133592 | Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart… | Neodent USA, Inc. | 2014 | — |
| −6 | K150367 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2015 | — |
| −5 | K170588 | DESS Dental Smart Solutions | Terrats Medical SL | 2017 | — |
| −4 | K173908 | DESS Dental Smart Solutions | Terrats Medical SL | 2018 | — |
| −3 | K191986 | DESS Dental Smart Solutions | Terrats Medical SL | 2019 | — |
| −2 | K202026 | Blue Sky Bio CAD-CAM Abutments | Blue Sky Bio, LLC | 2020 | — |
| −1 | K212108 | Dynamic TiBase | Talladium España, SL | 2021 | — |
| 0 (this device) | K231566 | ICX-Implant System | Medentis Medical GmbH | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 5 | 0 |
| 1990 | 7 | 0 |
| 1991 | 3 | 0 |
| 1992 | 5 | 0 |
| 1993 | 13 | 0 |
| 1994 | 14 | 0 |
| 1995 | 15 | 0 |
| 1996 | 17 | 0 |
| 1997 | 7 | 0 |
| 1998 | 8 | 0 |
| 1999 | 12 | 0 |
| 2000 | 11 | 0 |
| 2001 | 18 | 0 |
| 2002 | 20 | 0 |
| 2003 | 18 | 0 |
| 2004 | 21 | 0 |
| 2005 | 18 | 0 |
| 2006 | 26 | 0 |
| 2007 | 30 | 0 |
| 2008 | 25 | 0 |
| 2009 | 24 | 0 |
| 2010 | 18 | 0 |
| 2011 | 17 | 0 |
| 2012 | 10 | 0 |
| 2013 | 6 | 0 |
| 2014 | 6 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 6 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 4 | 0 |
| 2021 | 4 | 0 |
| 2022 | 3 | 0 |
| 2024 | 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? (15)
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 |
|---|---|---|---|
| * | K130222 | Straumann Dental Implant SystemSummary page 5…ENT and Dental Devices) Reviewing Division Division of Health Technology 1B (Dental and ENT Devices) PREDICATE DEVICE INFORMATION Primary Predicate Device K130222, Straumann® Dental Implant System SLActive and Roxolid Product Families, Straumann USA, Reference Devices K133510, Neodent Impla… | 2013 |
| * | K133510 | Neodent Implant SystemSummary page 5…PREDICATE DEVICE INFORMATION Primary Predicate Device K130222, Straumann® Dental Implant System SLActive and Roxolid Product Families, Straumann USA, Reference Devices K133510, Neodent Implant System, JJGC Indústria e Comércio de Materiais Dentarios SA K163194, Neodent Implant System - GM Line, JJGC Indú… | 2014 |
| * | K163194 | Neodent Implant System - GM LineSummary page 5…lant System SLActive and Roxolid Product Families, Straumann USA, Reference Devices K133510, Neodent Implant System, JJGC Indústria e Comércio de Materiais Dentarios SA K163194, Neodent Implant System - GM Line, JJGC Indústria e Comércio de Materiais Dentários SA K222288, DESS Dental Smart Solutions, Terr… | 2017 |
| * | K222288 | DESS Dental Smart SolutionsSummary page 5…eodent Implant System, JJGC Indústria e Comércio de Materiais Dentarios SA K163194, Neodent Implant System - GM Line, JJGC Indústria e Comércio de Materiais Dentários SA K222288, DESS Dental Smart Solutions, Terrats Medical SL K193096, S.I.N. Dental Implant System, S.I.N. –Sistema de Implante Nacional S.A.… | 2022 |
| * | K193096 | S.I.N. Dental Implant SystemSummary page 5…iais Dentarios SA K163194, Neodent Implant System - GM Line, JJGC Indústria e Comércio de Materiais Dentários SA K222288, DESS Dental Smart Solutions, Terrats Medical SL K193096, S.I.N. Dental Implant System, S.I.N. –Sistema de Implante Nacional S.A. K213063, TLX SRAs and TLX Gold Abutments, Institut Strau… | 2020 |
| * | K213063 | TLX SRAs and TLX Gold AbutmentsSummary page 5…ércio de Materiais Dentários SA K222288, DESS Dental Smart Solutions, Terrats Medical SL K193096, S.I.N. Dental Implant System, S.I.N. –Sistema de Implante Nacional S.A. K213063, TLX SRAs and TLX Gold Abutments, Institut Straumann AG… | 2022 |
| * | K092035 | Bicon Implants with a 2.5MM Internal ConnectionSummary page 6…ICX-Implant System K231566 K092035, Bicon Implants with a 2.5 mm Internal Connection, Bicon, L.L.C. K140440, Noris Medical Dental Implants System, Noris Medical, Lt… | 2009 |
| * | K140440 | Noris Medical Dental Implants SystemSummary page 6…K231566 K092035, Bicon Implants with a 2.5 mm Internal Connection, Bicon, L.L.C. K140440, Noris Medical Dental Implants System, Noris Medical, Ltd. K193046, Straumann® Retentive System – Novaloc TiN Abutments, Institut… | 2014 |
| * | K193046 | Straumann® Retentive System – Novaloc TiN AbutmentsSummary page 6…K231566 K092035, Bicon Implants with a 2.5 mm Internal Connection, Bicon, L.L.C. K140440, Noris Medical Dental Implants System, Noris Medical, Ltd. K193046, Straumann® Retentive System – Novaloc TiN Abutments, Institut Straumann AG K153779, Abutment for Bridges, Altatec GmbH K203252,… | 2020 |
| * | K153779 | Abutment for BridgesSummary page 6…ion, Bicon, L.L.C. K140440, Noris Medical Dental Implants System, Noris Medical, Ltd. K193046, Straumann® Retentive System – Novaloc TiN Abutments, Institut Straumann AG K153779, Abutment for Bridges, Altatec GmbH K203252, Multi-unit Abutments for CONELOG®, BioHorizons Implant Systems, Inc. K191123, Multi-… | 2016 |
| * | K203252 | Multi-unit Abutments for CONELOGSummary page 6…ntal Implants System, Noris Medical, Ltd. K193046, Straumann® Retentive System – Novaloc TiN Abutments, Institut Straumann AG K153779, Abutment for Bridges, Altatec GmbH K203252, Multi-unit Abutments for CONELOG®, BioHorizons Implant Systems, Inc. K191123, Multi-unit Abutments, Medentika GmbH, Straumann US… | 2021 |
| * | K191123 | Multi-unit AbutmentsSummary page 6…– Novaloc TiN Abutments, Institut Straumann AG K153779, Abutment for Bridges, Altatec GmbH K203252, Multi-unit Abutments for CONELOG®, BioHorizons Implant Systems, Inc. K191123, Multi-unit Abutments, Medentika GmbH, Straumann USA, LLC K170131, TAV Medical Dental Implant System, Tav Medical Ltd. K233208, N… | 2020 |
| * | K170131 | TAV Medical Dental Implants SystemSummary page 6…for Bridges, Altatec GmbH K203252, Multi-unit Abutments for CONELOG®, BioHorizons Implant Systems, Inc. K191123, Multi-unit Abutments, Medentika GmbH, Straumann USA, LLC K170131, TAV Medical Dental Implant System, Tav Medical Ltd. K233208, NobelProcera® Titanium ASC Abutment, Nobel Biocare AB K212108, Dyna… | 2018 |
| * | K233208 | NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium Cleared while this submission was under review Summary page 6…ONELOG®, BioHorizons Implant Systems, Inc. K191123, Multi-unit Abutments, Medentika GmbH, Straumann USA, LLC K170131, TAV Medical Dental Implant System, Tav Medical Ltd. K233208, NobelProcera® Titanium ASC Abutment, Nobel Biocare AB K212108, Dynamic TiBase, Talladium España, SL INDICATIONS FOR USE STATEM… | 2024 |
| * | K212108 | Dynamic TiBaseSummary page 6…Abutments, Medentika GmbH, Straumann USA, LLC K170131, TAV Medical Dental Implant System, Tav Medical Ltd. K233208, NobelProcera® Titanium ASC Abutment, Nobel Biocare AB K212108, Dynamic TiBase, Talladium España, SL INDICATIONS FOR USE STATEMENT ICX Implant Systems is indicated for use in partially or fu… | 2021 |
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 28 years and passes through 10 companies; a new generation was cleared every 10 months on median.
- 53 of the 429 ancestors have a recall of any class.
- 8 other devices also cite its predicate K130222.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
ICX-Implant System is indicated for use in partially or fully edentulous patients to support maxillary and mandibular single-unit, multiple-unit, and overdenture dental restorations. ICX- Implant System is indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Implants with lengths less than 7.0 mm are indicated for delayed loading only. ICX-Implant System CAD CAM abutments are intended for use with…
Read the full statement (114 words)
ICX-Implant System is indicated for use in partially or fully edentulous patients to support maxillary and mandibular single-unit, multiple-unit, and overdenture dental restorations. ICX- Implant System is indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Implants with lengths less than 7.0 mm are indicated for delayed loading only.
ICX-Implant System CAD CAM abutments are intended for use with dental implants as a support for single unit or multiple unit prostheses in the maxilla or mandible of a partially or fully edentulous patient. All digitally designed abutments for use with ICX-Implant System CAD CAM abutments are intended to be manufactured at a medentis medical GmbH validated milling center.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231566 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231566: ICX-Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231566
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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