# K170287: Dental Implants OKTAGON Bone Level Tapered Design

- Pathway: 510(k) (Traditional)
- Applicant: Hager& Meisinger GmbH
- Decided: May 24, 2017 after 114 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: 13 generations back to K894595 (1990). 99 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 101 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143539: Dental Implant OKTAGON Bone Level, Hager& Meisinger GmbH (2015) Summary page 4.
- K140878: Straumann Bone Level Tapered Implant, Straumann USA, LLC (2014) Summary page 4.

## Most influential descendants
- K180360: OKTAGON Implant System (2018), 0 descendants of its own

## Indications for use
The Dental Implants OKTAGON® Bone Level Tapered Design 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/K170287
Methodology: https://510kreport.com/methodology