# K143539: Dental Implant OKTAGON Bone Level

- Pathway: 510(k) (Traditional)
- Applicant: Hager& Meisinger GmbH
- Decided: Aug 31, 2015 after 259 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: 8 generations back to K894844 (1990). 22 ancestors in all.
8 later devices descend from it; 5 cite it directly.
0 of 31 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.
- K062129: P.0004 Implants, Institut Straumann AG (2006) Summary page 4.
- K132214: Abutment RP, Abutment WP, Burn-Out Coping, Screws, Titanium Adhesive Base, Alligator Abutment, Solid Abutment, Retentive, Hager& Meisinger GmbH (2014) Summary page 4.
- K072071: Straumann P.004 Cementable Abutments, Temporary Copings  and Protective Caps, Institut Straumann AG (2007) Summary page 4.
- K080286: Cementable Abuntments; Temporary Copings; Protective Caps, Straumann USA (2008) Summary page 4.

## Most influential descendants
- K173819: MyPlant II Implant System (2018), 3 descendants of its own
- K183024: Implacil Implant System (2020), 2 descendants of its own
- K170287: Dental Implants OKTAGON Bone Level Tapered Design (2017), 1 descendant of its own
- K202832: Implacil Implant System (2021), 0 descendants of its own
- K192839: DSP Implant System (2021), 0 descendants of its own

## 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 implants are intended to be used with OKTAGON® Bone Level abutments and prosthetic parts. Dental Implant Abutments Bone Level are intended to provide support for prosthetic reconstructions. Prosthetic applications can include individual crowns, bridges, partial or total prostheses. Abutments can be used in single tooth replacements and multiple tooth restorations. The Abutments are intended to be compatible to OKTAGON® Bone Level implants with diameters 3.3mm, 4.1mm and 4.8mm and with the lengths 8mm, 10mm, 12mm and 14mm. The Oktagon Bone Level 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/K143539
Methodology: https://510kreport.com/methodology