Cleared Traditional

K941002 - AURIUM X6 (MEDIUM GOLD CROWN AND BRIDGE ALLOY)

K941002 is an FDA 510(k) clearance for AURIUM X6 (MEDIUM GOLD CROWN AND BRIDGE..., 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 30-day FDA review.

K941002 · Argen Precious Metals, Inc. · Dental device
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Mar 1994
Decision
30d
Days
Class 2
Risk

K941002 is an FDA 510(k) clearance for the AURIUM X6 (MEDIUM GOLD CROWN AND BRIDGE 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 March 31, 1994 after a review of 30 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 - K941002

510(k) Number K941002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1994
Decision Date March 31, 1994
Days to Decision 30 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 127d · This submission: 30d
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 K941002.
AURIUM G14
K940930 · Argen Precious Metals, Inc. · Apr 1994
AURIUM D17 (HIGH GOLD CROWN & BRIDGE ALLOY)
K940865 · Argen Precious Metals, Inc. · Mar 1994
AURIUM 50Y
K940929 · Argen Precious Metals, Inc. · Mar 1994
AURIUM 20% (LOW GOLD CROWN AND BRIDGE ALLOY)
K941003 · Argen Precious Metals, Inc. · Mar 1994
AURIUM C
K940789 · Argen Precious Metals, Inc. · Mar 1994
AURIUM G13 (HIGH GOLD CROWN AND BRIDGE ALLOY)
K940856 · Argen Precious Metals, Inc. · Mar 1994