# K180360: OKTAGON Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Hager& Meisinger GmbH
- Decided: May 10, 2018 after 90 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: 14 generations back to K894595 (1990). 100 ancestors in all.
No later device cites it as a predicate yet.
0 of 101 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170287: Dental Implants OKTAGON Bone Level Tapered Design, Hager& Meisinger GmbH (2017) Summary page 4.
- K143539: Dental Implant OKTAGON Bone Level, Hager& Meisinger GmbH (2015) Summary page 4.

## Indications for use
Dental implants OKTAGON® are surgically placed in the maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. The implants are intended to be used with OKTAGON® abutments and prosthetic parts. The implants are intended for delayed loading in a two-stage surgery or for immediate loading when good primary stability is achieved and with appropriate occlusal load.

Source page: https://510kreport.com/device/K180360
Methodology: https://510kreport.com/methodology