Cleared Traditional

K904343 - ARGENCO 22

K904343 is an FDA 510(k) clearance for ARGENCO 22, manufactured by Argen Precious Metals, Inc.. The device is a Class 2 Dental device with product code EJT cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K904343 · Argen Precious Metals, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1990
Decision
37d
Days
Class 2
Risk

K904343 is an FDA 510(k) clearance for the ARGENCO 22. 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 October 31, 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

FDA 510(k) Submission Details - K904343

510(k) Number K904343 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1990
Decision Date October 31, 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.

EJT Device Classification - Class 2, Special Controls

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 550
Devices cleared under the same product code (EJT) and FDA review panel - the closest regulatory comparables to K904343.
X-L AND X-LX
K905325 · Ivoclar North America, Inc. · Dec 1990
GDC-1475
K904614 · Deringer-Ney, Inc. · Dec 1990
ARGENCO 19
K904437 · Argen Precious Metals, Inc. · Nov 1990
PALLADIUS-V AND PALLADIUS-AG SEMI-PRECIOUS ALLOY
K902863 · Vident · Oct 1990
250 SL DENTAL CASTING ALLOY
K903537 · Leach and Dillon Co., Inc. · Oct 1990
HIGH FUSING WHITE CERAMIC SOLDER
K895058 · Leach and Dillon Co., Inc. · Oct 1990