# K131066: Axiom Reg

- Pathway: 510(k) (Traditional)
- Applicant: Anthogyr Sas
- Decided: Feb 21, 2014 after 311 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K960026 (1996). 55 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 58 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 1.
- K050406: Nobelspeedy Implants, Nobel Biocare AB (2005) Summary page 1.
- K073075: Frialit Plus, Xive S Plus, Xive TG Plus, Ankylos Plus, Dental Implant Systems, Dentsply International, Inc. (2008) Summary page 1.
- K083805: Ankylos C/X Dental Implant System, Dentsply Intl., Inc. (2009) Summary page 1.

## Most influential descendants
- K161177: Axiom PX (2017), 0 descendants of its own
- K141450: AXIOM 2.8 (2014), 0 descendants of its own

## Indications for use
Anthogyr AXIOM® REG implants are intended for use as artificial root structures for replacement of missing teeth. They can be used for stabilization of removable prostheses or fixation of single tooth restorations or partial dentures. The Axiom dental system is 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. Prefabricated components are intended for use as accessories to dental implants to support implant-suppored restorations.

Source page: https://510kreport.com/device/K131066
Methodology: https://510kreport.com/methodology