510(k) · Cleared
Recalled · Class II · 2016AXIOM 2.8
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Anthogyr Sas · DZE Implant, Endosseous, Root-Form
Cleared on Sep 17, 2014 as substantially equivalent to K101913 (Anthogyr Sas, 2011) and 4 other predicates after a 107-day review. Its family tree reaches back 12 generations to 1996. It has been recalled once.
- Decided
- Sep 17, 2014
- Review
- 107 days
- Class
- Class II
- Product code
- DZE
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 12 generations to K960026 (1996). 63 ancestors in all, the oldest K894595 (1990). 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 backK051614 Primaconnex Internal Connection Implant System, Primaconnex Internal…Lifecore Biomedical, Inc. · 2005 · Recalled
- 2 generations backK101913 Anthofit OI, Anthofit HE, Ossfit and AxiomAnthogyr Sas · 2011 · Recalled
- 1 generation backK131066 Axiom RegAnthogyr Sas · 2014
- This deviceK141450 AXIOM 2.8Anthogyr Sas · 2014
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 backK050506 Primasolo One-Piece Implants & Healing CapsLifecore Biomedical, Inc. · 2005
- 3 generations backK051614 Primaconnex Internal Connection Implant System, Primaconnex Internal…Lifecore Biomedical, Inc. · 2005 · Recalled
- 2 generations backK101913 Anthofit OI, Anthofit HE, Ossfit and AxiomAnthogyr Sas · 2011 · Recalled
- 1 generation backK131066 Axiom RegAnthogyr Sas · 2014
- This deviceK141450 AXIOM 2.8Anthogyr Sas · 2014
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 | K050506 | Primasolo One-Piece Implants & Healing Caps | Lifecore Biomedical, Inc. | 2005 | — |
| −3 | K051614 | Primaconnex Internal Connection Implant System, Primaconnex Internal… | Lifecore Biomedical, Inc. | 2005 | 5 |
| −2 | K101913 | Anthofit OI, Anthofit HE, Ossfit and Axiom | Anthogyr Sas | 2011 | 1 |
| −1 | K131066 | Axiom Reg | Anthogyr Sas | 2014 | — |
| 0 (this device) | K141450 | AXIOM 2.8 | Anthogyr Sas | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 4 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 8 | 0 |
| 2003 | 5 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 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 |
|---|---|---|---|
| * | K101913 | Anthofit OI, Anthofit HE, Ossfit and AxiomSummary page 5…TAL IMPLANT Class II Product Code DZE / NHA CFR section 21CFR 872.3640 Device panel DENTAL Axiom® REG (K101913/K131066) manufactured by Anthogyr NobelActive 3.0 (K102436) manufactured by Nobel Biocare Legally marketed… | 2011 |
| * | K131066 | Axiom RegSummary page 5…ANT Class II Product Code DZE / NHA CFR section 21CFR 872.3640 Device panel DENTAL Axiom® REG (K101913/K131066) manufactured by Anthogyr NobelActive 3.0 (K102436) manufactured by Nobel Biocare Legally marketed… | 2014 |
| * | K102436 | Nobel Active 3.0Summary page 5…21CFR 872.3640 Device panel DENTAL Axiom® REG (K101913/K131066) manufactured by Anthogyr NobelActive 3.0 (K102436) manufactured by Nobel Biocare Legally marketed 3.0 mm Integra CP Implant (K101849) manufactured by Bicon p… | 2010 |
| * | K101849 | Bicon Dental Implant System 3.0MM Bicon Dental ImplantSummary page 5…manufactured by Anthogyr NobelActive 3.0 (K102436) manufactured by Nobel Biocare Legally marketed 3.0 mm Integra CP Implant (K101849) manufactured by Bicon predicate devices Sendax MDI and MDI PLUS (K031106) manufactured by… | 2010 |
| * | K031106 | Imtec Sendax Mdi and Mdi Plus Endosseous Implant, Models OB-XX, SH-XX, Mob-22, MSH-XXSummary page 5…ly marketed 3.0 mm Integra CP Implant (K101849) manufactured by Bicon predicate devices Sendax MDI and MDI PLUS (K031106) manufactured by Imtec The AXIOM® 2.8 implant system has been designed in order… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 20, 2016 | Class II | Z-2754-2016 | Device Design | Following a FDA inspection showing that the firm failed to validate the design and process of its implants. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 8 months on median.
- 11 of the 63 ancestors have a recall of any class.
- 2 other devices also cite its predicate K101913.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
ANTHOGYR implants are intended for use as artificial root structures for
replacement of missing teeth. They can be used for fixation of single tooth
restorations.
ANTHOGYR dental systems are indicated for one-stage or two-stage surgery. It is
up to the practitioner to decide whether immediate or delayed loading is most
appropriate, based on clinical factors like good primary stability and appropriate
occlusal loading.
Axiom® 2.8 implants are indicated for single replacement of mandibular incisors
and lateral maxillary incisors in cases presenting a restricted mesiodistal space.
The prosthetic components of the Axiom 2.8 product line are intended to ensure
support for single crowns only.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K141450 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141450: AXIOM 2.8.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141450
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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