# K162073: Dental Implants OKTAGON Tissue Level and Bone Level

- Pathway: 510(k) (Traditional)
- Applicant: Hager& Meisinger GmbH
- Decided: Feb 24, 2017 after 212 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: 9 generations back to K894844 (1990). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122807: Dental Implant System, Hager& Meisinger GmbH (2014) Summary page 4.
- K143539: Dental Implant OKTAGON Bone Level, Hager& Meisinger GmbH (2015) Summary page 4.

## Indications for use
The implants are surgically placed in the maxillary and/ or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. The parts are intended to be used with OKTAGON® respectively Bone Level abutments and prosthetic parts. The OKTAGON Implant System is intended for delayed loading, or for immediate loading when good primary stability is achieved and with appropriate occlusal load.

Source page: https://510kreport.com/device/K162073
Methodology: https://510kreport.com/methodology