Cleared Traditional

K935972 - ARGELOY N.P. (V) (NON-PRECIOUS DENTAL A...

K935972 is the FDA 510(k) clearance for ARGELOY N.P. (V) (NON-PRECIOUS DENTAL A... by Argen Precious Metals, Inc.. It is a Class 2 Dental device (product code EJH) cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K935972 · Argen Precious Metals, Inc. · Dental device
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Optimized for regulatory review, auditing and printing
Jan 1994
Decision
44d
Days
Class 2
Risk

K935972 is an FDA 510(k) clearance for the ARGELOY N.P. (V) (NON-PRECIOUS DENTAL ALLOY FOR PROCELAIN APPLICATION). Classified as Alloy, Metal, Base (product code EJH), Class II - Special Controls.

Submitted by Argen Precious Metals, Inc. (San Diego, US). The FDA issued a Cleared decision on January 26, 1994 after a review of 44 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3710 - 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 K935972 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1993
Decision Date January 26, 1994
Days to Decision 44 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
83d faster than avg
Panel avg: 127d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EJH Alloy, Metal, Base
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3710
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 - EJH Alloy, Metal, Base

All 31
Devices cleared under the same product code (EJH) and FDA review panel - the closest regulatory comparables to K935972.
VIDENT 500 ALLOY AND VIDENT 550 BE ALLOY
K932893 · Vident · Mar 1994
R2+
K934758 · Jeneric/Pentron, Inc. · Feb 1994
ARGELOY PARTIAL (NON-PRECIOUS)
K935829 · Argen Precious Metals, Inc. · Jan 1994
ARGELITE 81SF+
K934768 · Argen Precious Metals, Inc. · Dec 1993
R1, R2, AND R1+
K922954 · Jeneric/Pentron, Inc. · Jul 1993
DW242-07 NON-PRECIOUS ALLOY F/ PORCELAIN FUS. MET.
K920561 · Ivoclar North America, Inc. · Mar 1992