Cleared Traditional

K903971 - ARGENCO 26B

K903971 is an FDA 510(k) clearance for ARGENCO 26B, manufactured by Argen Precious Metals, Inc.. The device is a Class 2 Dental device with product code EJS cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K903971 · Argen Precious Metals, Inc. · Dental device
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Dec 1990
Decision
111d
Days
Class 2
Risk

K903971 is an FDA 510(k) clearance for the ARGENCO 26B. Classified as Alloy, Other Noble Metal (product code EJS), Class II - Special Controls.

Submitted by Argen Precious Metals, Inc. (San Diego, US). The FDA issued a Cleared decision on December 17, 1990 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3060 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Argen Precious Metals, Inc. devices

FDA 510(k) Submission Details - K903971

510(k) Number K903971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1990
Decision Date December 17, 1990
Days to Decision 111 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 127d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJS Device Classification - Class 2, Special Controls

Product Code EJS Alloy, Other Noble Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3060
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 - EJS Alloy, Other Noble Metal

All 171
Devices cleared under the same product code (EJS) and FDA review panel - the closest regulatory comparables to K903971.
MAXIBOND
K911757 · Argen Precious Metals, Inc. · Jun 1991
ARGIPLUS
K910467 · Argen Precious Metals, Inc. · Apr 1991
DW237
K904876 · Ivoclar North America, Inc. · Apr 1991
ARGENCO III
K903009 · Argen Precious Metals, Inc. · Aug 1990
ARGENCO 34
K903060 · Argen Precious Metals, Inc. · Aug 1990
ARGENCO Y (TYPE III/IV DENTAL ALLOY CROWN/BRIDGE
K902665 · Argen Precious Metals, Inc. · Aug 1990