# K230104: Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL

- Pathway: 510(k) (Traditional)
- Applicant: Anthogyr
- Decided: Oct 16, 2023 after 276 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: 18 generations back to K960026 (1996). 145 ancestors in all.
No later device cites it as a predicate yet.
0 of 146 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203309: NUVO CF Implant System, JJGC Indústria e Comércio de Materiais Dentários S.A. (2021) Summary page 7.
- K191123: Multi-unit Abutments, Medentika GmbH (2020) Summary page 7.
- K192401: Straumann Screw-Retained Abutments, Straumann USA, LLC (2020) Summary page 7.
- K133421: Straumann Magellan (TM) Abutment,Protective Cap,Titanium Copings,Gold Chopings,Basal Screw, Straumann USA, LLC (2014) Summary page 7.
- K220251: Neodent Implant System - GM Narrow Implant System, Jjgc Industria E Comercio DE Materiais Dentarios S.A. (2022) Summary page 7.

## Indications for use
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.

Source page: https://510kreport.com/device/K230104
Methodology: https://510kreport.com/methodology