Cleared Abbreviated

K150919 - ArgenZ Esthetic Plus

K150919 is an FDA 510(k) clearance for ArgenZ Esthetic Plus, manufactured by The Argen Corporation. The device is a Class 2 Dental device with product code EIH cleared through the Abbreviated 510(k) pathway after a 98-day FDA review.

K150919 · The Argen Corporation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2015
Decision
98d
Days
Class 2
Risk

K150919 is an FDA 510(k) clearance for the ArgenZ Esthetic Plus. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by The Argen Corporation (San Diego, US). The FDA issued a Cleared decision on July 13, 2015 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6660 - 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

FDA 510(k) Submission Details - K150919

510(k) Number K150919 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2015
Decision Date July 13, 2015
Days to Decision 98 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
29d faster than avg
Panel avg: 127d · This submission: 98d
Pathway characteristics
Standards-based clearance path.

EIH Device Classification - Class 2, Special Controls

Product Code EIH Powder, Porcelain
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6660
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 - EIH Powder, Porcelain

All 401
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