510(k) · Cleared
ClearedAnthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Anthogyr · DZE Implant, Endosseous, Root-Form
Cleared on Oct 16, 2023 as substantially equivalent to K203309 (JJGC Indústria e Comércio de Materiais Dentários S.A., 2021) and 4 other predicates after a 276-day review. Its family tree reaches back 18 generations to 1996.
- Decided
- Oct 16, 2023
- Review
- 276 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 18 generations to K960026 (1996). 145 ancestors in all, the oldest K874590 (1988). No later device cites it as a predicate yet.
- Root · 18 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 14 generations between
- 3 generations backK173961 Straumann BLX Implant SystemInstitut Straumann AG · 2018
- 2 generations backK181703 Straumann BLX Line Extension - Implants, SRAs and Anatomic AbutmentsInstitut Straumann AG · 2018
- 1 generation backK192401 Straumann Screw-Retained AbutmentsStraumann USA, LLC · 2020
- This deviceK230104 Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for…Anthogyr · 2023
Show all 18 generations
- Root · 18 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 17 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 16 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 15 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 14 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 13 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 12 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 11 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 10 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 9 generations backK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
- 8 generations backK081653 Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · Recalled
- 7 generations backK123022 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013
- 6 generations backK133510 Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014
- 5 generations backK133592 Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua…Neodent USA, Inc. · 2014
- 4 generations backK150182 Neodent Implant System- CM Drive ImplantsJjgc Industria E Comercio DE Materiais Dentarios S · 2015
- 3 generations backK173961 Straumann BLX Implant SystemInstitut Straumann AG · 2018
- 2 generations backK181703 Straumann BLX Line Extension - Implants, SRAs and Anatomic AbutmentsInstitut Straumann AG · 2018
- 1 generation backK192401 Straumann Screw-Retained AbutmentsStraumann USA, LLC · 2020
- This deviceK230104 Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for…Anthogyr · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −17 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −16 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −15 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −14 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −13 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −12 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −11 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −10 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −9 | K063364 | Alpha Bio Dental Implant System | Alpha-Bio Tec, Ltd. | 2007 | — |
| −8 | K081653 | Mdi Mii One-Piece Implant, 2.9MM | Imtec Corp. | 2008 | 1 |
| −7 | K123022 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2013 | — |
| −6 | K133510 | Neodent Implant System | Jj Industria E Comercio DE Materiais Dentarios SA | 2014 | — |
| −5 | K133592 | Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart… | Neodent USA, Inc. | 2014 | — |
| −4 | K150182 | Neodent Implant System- CM Drive Implants | Jjgc Industria E Comercio DE Materiais Dentarios S | 2015 | — |
| −3 | K173961 | Straumann BLX Implant System | Institut Straumann AG | 2018 | — |
| −2 | K181703 | Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments | Institut Straumann AG | 2018 | — |
| −1 | K192401 | Straumann Screw-Retained Abutments | Straumann USA, LLC | 2020 | — |
| 0 (this device) | K230104 | Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL | Anthogyr | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 3 | 0 |
| 1992 | 2 | 0 |
| 1993 | 4 | 0 |
| 1994 | 4 | 0 |
| 1995 | 5 | 0 |
| 1996 | 10 | 0 |
| 1997 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 7 | 0 |
| 2000 | 8 | 0 |
| 2001 | 13 | 0 |
| 2002 | 16 | 0 |
| 2003 | 11 | 0 |
| 2004 | 10 | 0 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 4 | 0 |
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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? (5)
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 |
|---|---|---|---|
| * | K203309 | NUVO CF Implant SystemSummary page 7…Anthogyr AXIOM® BL X3 implants and Anthogyr Multi-Unit components for AXIOM® BL Predicate Device(s) Primary Predicate: • K203309 – NUVO CF Implant System Reference Devices: • K161177 – AXIOM® PX • K173961 – Straumann BLX Implant System… | 2021 |
| * | K191123 | Multi-unit AbutmentsSummary page 7…177 – AXIOM® PX • K173961 – Straumann BLX Implant System • K131066 – Axiom® REG • K101913 – ANTHOGYR DENTAL IMPLANT SYSTEMS : AXIOM • K191123 – Medentika Multi-unit Abutments • K192401 – Straumann® Screw-Retained Abutments • K133421 – Straumann® Magella… | 2020 |
| * | K192401 | Straumann Screw-Retained AbutmentsSummary page 7…mplant System • K131066 – Axiom® REG • K101913 – ANTHOGYR DENTAL IMPLANT SYSTEMS : AXIOM • K191123 – Medentika Multi-unit Abutments • K192401 – Straumann® Screw-Retained Abutments • K133421 – Straumann® Magellan Abutment System • K220251 – Neodent Impla… | 2020 |
| * | K133421 | Straumann Magellan (TM) Abutment,Protective Cap,Titanium Copings,Gold Chopings,Basal ScrewSummary page 7…K101913 – ANTHOGYR DENTAL IMPLANT SYSTEMS : AXIOM • K191123 – Medentika Multi-unit Abutments • K192401 – Straumann® Screw-Retained Abutments • K133421 – Straumann® Magellan Abutment System • K220251 – Neodent Implant System – GM Narrow Implant System • K033922 -… | 2014 |
| * | K220251 | Neodent Implant System - GM Narrow Implant SystemSummary page 7…K191123 – Medentika Multi-unit Abutments • K192401 – Straumann® Screw-Retained Abutments • K133421 – Straumann® Magellan Abutment System • K220251 – Neodent Implant System – GM Narrow Implant System • K033922 - Straumann® Modification to ITI Dental Implant System De… | 2022 |
| † | K161177 | Axiom PX | 2017 |
| † | K173961 | Straumann BLX Implant System | 2018 |
| † | K131066 | Axiom Reg | 2014 |
| † | K101913 | Anthofit OI, Anthofit HE, Ossfit and Axiom | 2011 |
| † | K033922 | Modification to Iti Dental Implant System | 2004 |
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 27 years and passes through 9 companies; a new generation was cleared every 9 months on median.
- 14 of the 145 ancestors have a recall of any class.
- 2 other devices also cite its predicate K203309.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
The implant system is intended to be surgically placed in the maxilla or mandible to provide support for prosthetic devices such as artificial teeth in order to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted. Anthogyr…
Read the full statement (165 words)
The implant system is intended to be surgically placed in the maxilla or mandible to provide support for prosthetic devices such as artificial teeth in order to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted.
Anthogyr Multi-Unit prosthetic components directly or indirectly connected to the endosseous dental implants are indicated for use to provide support for multiple-unit prosthetic reconstructions such as bridges and bars. The final devices have the purpose of restoring chewing function. Temporary components can be used prior to the installation of the final components to maintain, stabilize and shape the soft tissue during the healing phase. The temporary restoration may not be placed into occlusion.
Temporary components have a maximum duration of usage of 180 days.
The OPMUN0-0 abutments are indicated for maxillary lateral and mandibular central/lateral incisors only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230104 · printed Nov 4, 2026
Cite this page
510(k) Report. “K230104: Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K230104
Report an extraction error
Are you the manufacturer?
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