# K170031: Internal Octa Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Ebi, Inc.
- Decided: Aug 31, 2017 after 239 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: 6 generations back to K894595 (1990). 17 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073116: Ebi Internal Implant System, Ebi, Inc. (2008) Summary page 5.

## Most influential descendants
- K190837: Internal Hex Implant System (2020), 0 descendants of its own

## Indications for use
The Internal Octa Implant System is intended for placement in the maxillary and/or mandibular arches to support crowns, bridges, or overdentures in edentulous or partially edentulous patients. The Internal Octa Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Source page: https://510kreport.com/device/K170031
Methodology: https://510kreport.com/methodology