# K121843: NP-Cast Abutment System

- Pathway: 510(k) (Traditional)
- Applicant: Osstem Implant Co., Ltd.
- Decided: Dec 11, 2012 after 169 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: 9 generations back to K894595 (1990). 25 ancestors in all.
54 later devices descend from it; 4 cite it directly.
0 of 80 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112045: Simpleline II Abutment System, Dentium Co., Ltd. (2012) Summary page 2.
- K081575: HU/HS/HG Prosthetic System, Osstem Implant Co., Ltd. (2008) Summary page 1.

## Cited in the summary but kept off the family tree
- K103308: Aida HD Connect with Smartscreen / Blu-Ray Drive / Smartscreen with Blu-Ray Drive, KARL STORZ Endoscopy-America, Inc. (2011). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- 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
- K211090: ZENEX Implant System (2022), 8 descendants of its own

## Indications for use
NP-Cast Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

Source page: https://510kreport.com/device/K121843
Methodology: https://510kreport.com/methodology