# K102308: Simpleline II Model SOFX483408R, SOFX483410R Total 44 Models

- Pathway: 510(k) (Special)
- Applicant: Dentium Co., Ltd.
- Decided: Nov 22, 2010 after 98 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: 2 generations back to K041368 (2004). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060501: Implantium II, Dentium Co., Ltd. (2006) Summary page 1.

## Indications for use
SimpleLine II is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetics devices, such as artificial teeth, and to restore the patient's chewing function. SimpleLine II is for single stage surgery

Source page: https://510kreport.com/device/K102308
Methodology: https://510kreport.com/methodology