Cleared Traditional

K902904 - ARGENCO 20 (20 CT) TYPE II DENTAL GOLD ...

K902904 is the FDA 510(k) clearance for ARGENCO 20 (20 CT) TYPE II DENTAL GOLD ... by Argen Precious Metals, Inc.. It is a Class 2 Dental device (product code EJT) cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K902904 · Argen Precious Metals, Inc. · Dental device
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Aug 1990
Decision
37d
Days
Class 2
Risk

K902904 is an FDA 510(k) clearance for the ARGENCO 20 (20 CT) TYPE II DENTAL GOLD ALLOY. Classified as Alloy, Gold-based Noble Metal (product code EJT), Class II - Special Controls.

Submitted by Argen Precious Metals, Inc. (San Diego, US). The FDA issued a Cleared decision on August 9, 1990 after a review of 37 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Argen Precious Metals, Inc. devices

Submission Details

510(k) Number K902904 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1990
Decision Date August 09, 1990
Days to Decision 37 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
90d faster than avg
Panel avg: 127d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EJT Alloy, Gold-based 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 - EJT Alloy, Gold-based Noble Metal

All 377
Devices cleared under the same product code (EJT) and FDA review panel - the closest regulatory comparables to K902904.
ARGENCO M-1 TYPE II DENTAL GOLD ALLOY
K902900 · Argen Precious Metals, Inc. · Aug 1990
ARGENCO 16 TYPE I DENTAL GOLD ALLOY
K902901 · Argen Precious Metals, Inc. · Aug 1990
ARGENCO 17 TYPE II DENTAL GOLD ALLOY
K902903 · Argen Precious Metals, Inc. · Aug 1990
ARGENCO 18
K903059 · Argen Precious Metals, Inc. · Aug 1990
ARGENCO 1
K903119 · Argen Precious Metals, Inc. · Aug 1990
ARGENCO 23
K903120 · Argen Precious Metals, Inc. · Aug 1990