# K160248: ArgenIS Titanium Abutments

- Pathway: 510(k) (Abbreviated)
- Applicant: Argen Corporation
- Decided: Aug 5, 2016 after 186 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: 10 generations back to K894595 (1990). 108 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 110 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143051: ArgenIS Titanium Abutments, The Argen Corporation (2015) Summary page 5.

## Most influential descendants
- K172430: ArgenIS Titanium Abutments (2018), 0 descendants of its own

## Indications for use
ArgenIS Titanium Abutments are intended to be single use available by prescription only in the construction of dental restorations supported by the endosseous dental implant. The ArgenIs Titanium Abutments are designed to specifically fit an individual patient’s needs of the final restoration. All digitally designed abutments files are intended to be sent to Argen manufacturer for milling.

Source page: https://510kreport.com/device/K160248
Methodology: https://510kreport.com/methodology