# K112045: Simpleline II Abutment System

- Pathway: 510(k) (Abbreviated)
- Applicant: Dentium Co., Ltd.
- Decided: Jan 26, 2012 after 192 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K931767 (1994). 4 ancestors in all.
60 later devices descend from it; 5 cite it directly.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070228: Implantium Prosthetics, Dentium Co., Ltd. (2007) Summary page 1.
- K052957: Implantium Prosthetics, Dentium Co., Ltd. (2006) Summary page 1.
- K041368: Dentium CO., LTD. Implantium, Dentium Co., Ltd. (2004) Summary page 1.

## Most influential descendants
- K121843: NP-Cast Abutment System (2012), 54 descendants of its own
- K140507: Hiossen Prosthetic System (2014), 44 descendants of its own
- K160670: ET US SS Prosthetic system (2017), 32 descendants of its own
- K182091: Osstem Abutment System (2019), 30 descendants of its own
- K153521: IH Implant System (2016), 10 descendants of its own

## Indications for use
The SimpleLine II Abutment System is intended for use as an aid in prosthetic rehabilitation.

Source page: https://510kreport.com/device/K112045
Methodology: https://510kreport.com/methodology