Cleared Traditional

K893566 - ARGENCO 50 TYPE IV TYPE IV DENTAL GOLD ALLOY

K893566 is an FDA 510(k) clearance for ARGENCO 50 TYPE IV TYPE IV DENTAL GOLD ..., 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 66-day FDA review.

K893566 · Argen Precious Metals, Inc. · Dental device
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Jul 1989
Decision
66d
Days
Class 2
Risk

K893566 is an FDA 510(k) clearance for the ARGENCO 50 TYPE IV TYPE IV 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 July 14, 1989 after a review of 66 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 - K893566

510(k) Number K893566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1989
Decision Date July 14, 1989
Days to Decision 66 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
61d faster than avg
Panel avg: 127d · This submission: 66d
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 K893566.
MONOGRAM II
K895064 · Leach and Dillon Co., Inc. · Dec 1989
MONOGRAM III
K895065 · Leach and Dillon Co., Inc. · Dec 1989
SELECT 50
K895068 · Leach and Dillon Co., Inc. · Dec 1989
ARGENCO 68 TYPE IV DENTAL GOLD ALLOY
K893565 · Argen Precious Metals, Inc. · Jun 1989
ARGENCO 56 TYPE IV DENTAL GOLD ALLOY
K893568 · Argen Precious Metals, Inc. · Jun 1989
ARGELOY N.P.
K893686 · Argen Precious Metals, Inc. · Jun 1989