# K073116: Ebi Internal Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Ebi, Inc.
- Decided: Feb 28, 2008 after 115 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: 5 generations back to K894595 (1990). 16 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051576: Avana Dental Implant System, Osstem Co., Ltd. (2005) Summary page 1.
- K003552: Iti Dental Implant System, Institut Straumann SA (2001) Summary page 1.

## Most influential descendants
- K170031: Internal Octa Implant System (2017), 1 descendant of its own
- K190837: Internal Hex Implant System (2020), 0 descendants of its own
- K142426: EBI External Implant System (2015), 0 descendants of its own

## Indications for use
Intended for immediate, delayed, or conventional placement in the maxillary and/or mandibular arches to support crowns, bridges or overdentures in edentulous or partially edentulous patients.

Source page: https://510kreport.com/device/K073116
Methodology: https://510kreport.com/methodology