# K083669: OBI

- Pathway: 510(k) (Traditional)
- Applicant: Euroteknika
- Decided: Jun 8, 2009 after 179 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: 10 generations back to K960026 (1996). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050970: Milo Dental Implant System, Intra-Lock International (2005) Summary page 1.
- K972351: Sendax Mdi (Mini Dental Implant), Sendax Mdic Management, Inc. (1997) Summary page 1.
- K011245: Advent Implant System, Swiss Plus Implant System, Sulzer Dental, Inc. (2001) Summary page 1.
- K070601: Mini Drive-Lock Dental Implant System, Intra-Lock International (2007) Summary page 1.

## Indications for use
Surgical placement in mandibular arch to support overdentures in edentulous patients.

Source page: https://510kreport.com/device/K083669
Methodology: https://510kreport.com/methodology