# K143051: ArgenIS Titanium Abutments

- Pathway: 510(k) (Abbreviated)
- Applicant: The Argen Corporation
- Decided: Sep 16, 2015 after 328 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). 107 ancestors in all.
2 later devices descend 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)
- K062566: Nobelreplace Tapered Conical Connection, Nobel Biocare USA, LLC (2006) Summary page 4.
- K130949: CP4 Osseotite Certain Dental Implants, Biomet 3i (2013) Summary page 4.
- K081419: Straumann Dental Implant System, Institut Straumann AG (2009) Summary page 4.
- K133339: Zimmer Dental Tapered Screw Vent T Implant, HA Coated;Zimmer Dental Tapered Screw-Vent M Implant, HA Coated, Zimmer Dental, Inc. (2014) Summary page 5.
- K083192: Inclusive Titanium Abutment Blanks, Inclusive Dental Solutions (2009) Summary page 5.
- K130183: Sfi Bar Abutments, Sterngold Dental, LLC (2013) Summary page 5.
- K132814: Sfi-Bar Implant Abutments, Sterngold Dental, LLC (2014) Summary page 5.

## Most influential descendants
- K160248: ArgenIS Titanium Abutments (2016), 1 descendant of its own
- K172430: ArgenIS Titanium Abutments (2018), 0 descendants of its own

## Indications for use
ArgenIS patient specific abutments are intended to be single use available by prescription only to dental professionals (dental technicians and Dentists) in the construction of dental restorations supported by endosseous dental implants. The Argen Is Abutment is designed to specifically fit an individual patients needs in order to more naturally support the tissue, esthetics, and function of the final restoration. The ArgenIS titanium abutments are compatible with the following implant systems: Implant Brand and Type Implant Diameter Nobel Biocare Replace Select 3.5mm Nobel Biocare Replace Select 4.3mm Nobel Biocare Replace Select 5.0mm Biomet 3i Certain 3.25mm Biomet 3i Certain 4.0mm Biomet 3i Certain 5.0mm Straumann Tissue Level - RN 3.3mm Straumann Tissue Level - RN 4.1mm Straumann Tissue Level - RN 4.8mm Zimmer Tapered Screw-Vent 3.7mm Zimmer Tapered Screw-Vent 4.1mm Zimmer Tapered Screw-Vent 4.7mm Zimmer Tapered Screw-Vent 6.0mm

Source page: https://510kreport.com/device/K143051
Methodology: https://510kreport.com/methodology