FDA device listing

ArgenIS

FDA device listing 1420552910 · The Argen Corporation

Key facts

Proprietary names ArgenIS
Owner/operator The Argen Corporation
Owner/operator number 9021799
Product codes NHA
Device names NHA - Abutment, Implant, Dental, Endosseous
Device class Class II
Classification regulations (21 CFR) 872.3630
Review panels Dental
Registered establishments The Argen Corporation, THE ARGEN CORPORATION
Establishment registrations 2433919, 3013551048
FEI numbers 2433919, 3013551048
Establishment operations Contract Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None listed Premarket submission listed

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device listings

Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.

Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database

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