Cleared Traditional

K893010 - ARGELITE 54+

K893010 is the FDA 510(k) clearance for ARGELITE 54+ by Argen Precious Metals, Inc.. It is a Class 2 Dental device (product code EJT) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K893010 · Argen Precious Metals, Inc. · Dental device
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Jun 1989
Decision
43d
Days
Class 2
Risk

K893010 is an FDA 510(k) clearance for the ARGELITE 54+. 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 June 6, 1989 after a review of 43 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 K893010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1989
Decision Date June 06, 1989
Days to Decision 43 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
84d faster than avg
Panel avg: 127d · This submission: 43d
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 K893010.
MODIFIED ULTIMA LITE
K892144 · Deringer-Ney, Inc. · Jun 1989
ARGENCO W
K893237 · Argen Precious Metals, Inc. · Jun 1989
CASTING ALLOY FOR PORCELAIN-FUSED-TO-METAL RESTOR.
K892907 · Deringer-Ney, Inc. · Jun 1989
ARGENCO W-LITE
K893228 · Argen Precious Metals, Inc. · Jun 1989
ARGENCO WLF
K893238 · Argen Precious Metals, Inc. · Jun 1989
ARGENCO WR+
K893244 · Argen Precious Metals, Inc. · Jun 1989