# K111162: Slim Onebody System

- Pathway: 510(k) (Abbreviated)
- Applicant: Dentium Co., Ltd.
- Decided: Jan 13, 2012 after 263 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: 1 generation back to K031106 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031106: Imtec Sendax Mdi and Mdi Plus Endosseous Implant, Models OB-XX, SH-XX, Mob-22, MSH-XX, Imtec Corp. (2003) Summary page 1.

## Indications for use
The Slim Onebody System is intended for immediate loading in partially or fully edentulous mandibles aid maxillae to serve as temporary support for provisional prosthetic device during the healing phase (maximum six months) of permanent endosseous dental implants.

Source page: https://510kreport.com/device/K111162
Methodology: https://510kreport.com/methodology