Cleared Traditional

K903686 - ARGILITE 4 GOLD ALLOY FOR PORCELAIN

K903686 is an FDA 510(k) clearance for ARGILITE 4 GOLD ALLOY FOR PORCELAIN, manufactured by Argen Precious Metals, Inc.. The device is a Class 1 Dental device with product code EFT cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K903686 · Argen Precious Metals, Inc. · Dental device
Download Printable Device Report (PDF)
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Aug 1990
Decision
16d
Days
Class 1
Risk

K903686 is an FDA 510(k) clearance for the ARGILITE 4 GOLD ALLOY FOR PORCELAIN. Classified as Cleanser, Denture, Over The Counter (product code EFT), Class I - General Controls.

Submitted by Argen Precious Metals, Inc. (San Diego, US). The FDA issued a Cleared decision on August 29, 1990 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3520 - 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.

FDA 510(k) Submission Details - K903686

510(k) Number K903686 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1990
Decision Date August 29, 1990
Days to Decision 16 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
112d faster than avg
Panel avg: 128d · This submission: 16d
Pathway characteristics
Predicate-based equivalence.

EFT Device Classification - Class 1, General Controls

Product Code EFT Cleanser, Denture, Over The Counter
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3520
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EFT Cleanser, Denture, Over The Counter

All 25
Devices cleared under the same product code (EFT) and FDA review panel - the closest regulatory comparables to K903686.
DENTURE PRODUCT X
K914257 · Essential Dental Systems, Inc. · Jan 1993
CFR MONOGRAPH
K925259 · Combe, Inc. · Jan 1993
DENTURE DYNAMIC'S DENTURE MAGIC
K902838 · Denture Dynamic'S, Inc. · Sep 1990
ORAD TOOTHBRUSH CLEANER
K895345 · Orad, Inc. · Mar 1990
DENTCLEAN CONCENTRATED DENTURE CLEANSER
K890043 · K-P Co. · Jun 1989
CLEAN DENT
K890668 · Lincoln Park Dental Laboratory · Apr 1989
K903686 · ARGILITE 4 GOLD ALLOY FOR PORCELAIN
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