Cleared Traditional

K934773 - ARGELITE A

K934773 is the FDA 510(k) clearance for ARGELITE A by Argen Precious Metals, Inc.. It is a Class 2 Dental device (product code EJS) cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K934773 · Argen Precious Metals, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1993
Decision
66d
Days
Class 2
Risk

K934773 is an FDA 510(k) clearance for the ARGELITE A. Classified as Alloy, Other Noble Metal (product code EJS), Class II - Special Controls.

Submitted by Argen Precious Metals, Inc. (San Diego, US). The FDA issued a Cleared decision on December 10, 1993 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

Submission Details

510(k) Number K934773 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1993
Decision Date December 10, 1993
Days to Decision 66 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
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.

Device Classification

Product Code EJS Alloy, Other 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 - EJS Alloy, Other Noble Metal

All 110
Devices cleared under the same product code (EJS) and FDA review panel - the closest regulatory comparables to K934773.
AUROFLUID 22
K970044 · Metalor Dental USA Corp. · Mar 1997
SOLARO 33
K970045 · Metalor Dental USA Corp. · Mar 1997
CU-FREE & LTA
K934757 · Jeneric/Pentron, Inc. · Feb 1994
VS 1A
K933563 · Metalor Dental USA Corp. · Oct 1993
CORRECT AND CORRECT FIT II
K925331 · Jeneric/Pentron, Inc. · May 1993
BIO C & B
K926146 · Jeneric/Pentron, Inc. · May 1993