# K160132: Dental Implant Abutment OKTAGON Bone Level RC, Dental Implant Abutment OKTAGON Bone Level NC

- Pathway: 510(k) (Traditional)
- Applicant: Hager& Meisinger GmbH
- Decided: Nov 21, 2016 after 306 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- 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)
- K143539: Dental Implant OKTAGON Bone Level, Hager& Meisinger GmbH (2015) Summary page 4.

## Indications for use
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, 4.1lmm and 4.8mm and with the lengths 8mm, 10mm, 12mm and 14mm. The Dental Implant System OKTAGON® Bone Level 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/K160132
Methodology: https://510kreport.com/methodology