Cleared Abbreviated

K143051 - ArgenIS Titanium Abutments

K143051 is the FDA 510(k) clearance for ArgenIS Titanium Abutments by The Argen Corporation. It is a Class 2 Dental device (product code NHA) cleared through the Abbreviated 510(k) pathway after a 328-day FDA review.

K143051 · The Argen Corporation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2015
Decision
328d
Days
Class 2
Risk

K143051 is an FDA 510(k) clearance for the ArgenIS Titanium Abutments. Classified as Abutment, Implant, Dental, Endosseous within the NHA classification (a category for dental implant abutments and prosthetic components), Class II - Special Controls.

Submitted by The Argen Corporation (San Diego, US). The FDA issued a Cleared decision on September 16, 2015 after a review of 328 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3630 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all The Argen Corporation devices

Submission Details

510(k) Number K143051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 2014
Decision Date September 16, 2015
Days to Decision 328 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
201d slower than avg
Panel avg: 127d · This submission: 328d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code NHA Abutment, Implant, Dental, Endosseous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3630
Definition To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - NHA Abutment, Implant, Dental, Endosseous

All 469
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K143051.
Inclusive Titanium Abutments compatible with: Straumann synOcta Implant System
K151798 · Prismatik Dentalcraft, Inc. · Nov 2015
Inclusive Titanium Abutments compatible with: Hiossen HG Implant System
K151375 · Prismatik Dentalcraft, Inc. · Oct 2015
Inclusive® Zirconia Abutments compatible with: Zimmer Screw-Vent, Biomet 3i Certain and Nobel Biocare NobelReplace Implants
K143515 · Prismatik Dentalcraft, Inc. · Oct 2015
Zimmer Patient-Specific Abutment, Internal Hex, Titanium
K143505 · Zimmer Dental, Inc. · Jun 2015
Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System
K143528 · Zimmer Dental, Inc. · May 2015
Zimmer Zfx Abutment for Zimmer 3.1mmD Implant System
K142572 · Zimmer Dental, Inc. · Jan 2015