Cleared Traditional

K891989 - ARGEDENT 52 (DENTAL ALLOY)

K891989 is the FDA 510(k) clearance for ARGEDENT 52 (DENTAL ALLOY) by Argen Precious Metals, Inc.. It is a Class 2 Dental device (product code EJT) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K891989 · Argen Precious Metals, Inc. · Dental device
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May 1989
Decision
63d
Days
Class 2
Risk

K891989 is an FDA 510(k) clearance for the ARGEDENT 52 (DENTAL 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 May 30, 1989 after a review of 63 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 K891989 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1989
Decision Date May 30, 1989
Days to Decision 63 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
64d faster than avg
Panel avg: 127d · This submission: 63d
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 K891989.
ARGEDENT 62 DENTAL ALLOY
K892709 · Argen Precious Metals, Inc. · Jun 1989
ARGEDENT 35SF
K892810 · Argen Precious Metals, Inc. · Jun 1989
ARGEDENT 74 DENTAL ALLOY FOR PORCELAIN APPLI.
K892335 · Argen Precious Metals, Inc. · May 1989
ARGEDENT 87
K892662 · Argen Precious Metals, Inc. · May 1989
ARGELITE 60+
K893012 · Argen Precious Metals, Inc. · May 1989
ARGEDENT 45
K892814 · Argen Precious Metals, Inc. · May 1989