Cleared Traditional

K940434 - AUROLITE 2B

K940434 is the FDA 510(k) clearance for AUROLITE 2B by Argen Precious Metals, Inc.. It is a Class 2 Dental device (product code EJT) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K940434 · Argen Precious Metals, Inc. · Dental device
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Mar 1994
Decision
35d
Days
Class 2
Risk

K940434 is an FDA 510(k) clearance for the AUROLITE 2B. 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 7, 1994 after a review of 35 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 K940434 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1994
Decision Date March 07, 1994
Days to Decision 35 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
92d faster than avg
Panel avg: 127d · This submission: 35d
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 K940434.
AUROLITE 9
K940610 · Argen Precious Metals, Inc. · Mar 1994
DW246 #43
K926177 · Ivoclar North America, Inc. · Mar 1994
AUROLITE 1C
K940361 · Argen Precious Metals, Inc. · Mar 1994
AUROLITE 54+2
K940435 · Argen Precious Metals, Inc. · Mar 1994
SUREFIRE 10
K940282 · Argen Precious Metals, Inc. · Mar 1994
SILFREE 2 HIGH-PALLADIUM ALLOY FOR PORCELAIN APPLICATION
K940337 · Argen Precious Metals, Inc. · Mar 1994