← Back to catalogue

ArgenIS Titanium Abutments

FDA 510(k)

Class II (US FDA 510(k))

510(k) K160248

by Argen Corporation

Identifiers

510(k) Number
K160248 FDA 510(k)
FDA Product Code
NHA FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3630 FDA 510(k)
Regulation Number
872.3630 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

ArgenIS Titanium Abutments are dental abutments designed for use with implant systems. These custom components are milled from medical grade 5 ELI titanium to support individual glued ceramic abutments or synthetic restorations.

The abutments are available in straight, 17-degree, and 30-degree angulations with multiple gingival height options. This device has received FDA 510K clearance under K160248.

Frequently asked questions

What are ArgenIS Titanium Abutments used for?

These components are designed for use with dental implant systems. They serve as a support structure for individual glued ceramic abutments or synthetic restorations.

What material is used to manufacture these abutments?

ArgenIS Titanium Abutments are milled from medical grade 5 ELI titanium. This material is selected for its suitability in dental implant applications.

What angulations and sizes are available for this device?

The abutments are available in straight, 17-degree, and 30-degree angulations. They also offer multiple gingival height options to accommodate different clinical requirements.

What is the regulatory status of the ArgenIS Titanium Abutments?

This device has received FDA 510K clearance under K160248. The submission was reviewed by the dental advisory committee and determined to be substantially equivalent to existing devices.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ArgenIS Titanium Abutment | Argen, Abutment Design | Argen, ArgenIS Multi-Unit Abutment | Argen

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Argen Corporation

Sources (1)

  • FDA 510(k) K160248 24 fields · synced Sep 22, 2026