# K142426: EBI External Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Ebi, Inc.
- Decided: Mar 27, 2015 after 210 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: 12 generations back to K925765 (1993). 99 ancestors in all.
No later device cites it as a predicate yet.
0 of 100 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.
- K111216: Osseotite 2 Dental Implants, Biomet 3i, Inc. (2011) Summary page 5.
- K063286: Osseotite; Osseotite NT; XP; TG Osseotite, Implant Innovations, Inc. (2007) Summary page 5.
- K052369: Exfeel Implant System, Megagen Co., Ltd. (2006) Summary page 5.

## Indications for use
EBI Dental Implant System is 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/K142426
Methodology: https://510kreport.com/methodology