# K141450: AXIOM 2.8

- Pathway: 510(k) (Abbreviated)
- Applicant: Anthogyr Sas
- Decided: Sep 17, 2014 after 107 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K960026 (1996). 63 ancestors in all.
No later device cites it as a predicate yet.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101913: Anthofit OI, Anthofit HE, Ossfit and Axiom, Anthogyr Sas (2011) Summary page 5.
- K131066: Axiom Reg, Anthogyr Sas (2014) Summary page 5.
- K102436: Nobel Active 3.0, Nobel Biocare AB (2010) Summary page 5.
- K101849: Bicon Dental Implant System 3.0MM Bicon Dental Implant, Bicon, LLC (2010) Summary page 5.
- K031106: Imtec Sendax Mdi and Mdi Plus Endosseous Implant, Models OB-XX, SH-XX, Mob-22, MSH-XX, Imtec Corp. (2003) Summary page 5.

## Recalls of this device
- Jun 20, 2016 · Class II · Z-2754-2016: Following a FDA inspection showing that the firm failed to validate the design and process of its implants.

## Indications for use
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.

Source page: https://510kreport.com/device/K141450
Methodology: https://510kreport.com/methodology