Cleared Traditional

K913704 - ARGEBOND 80

K913704 is an FDA 510(k) clearance for ARGEBOND 80, manufactured by Argen Precious Metals, Inc.. The device is a Class 2 Dental device with product code EJS cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K913704 · Argen Precious Metals, Inc. · Dental device
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Nov 1991
Decision
86d
Days
Class 2
Risk

K913704 is an FDA 510(k) clearance for the ARGEBOND 80. 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 November 13, 1991 after a review of 86 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

FDA 510(k) Submission Details - K913704

510(k) Number K913704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1991
Decision Date November 13, 1991
Days to Decision 86 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
41d faster than avg
Panel avg: 127d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJS Device Classification - Class 2, Special Controls

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 171
Devices cleared under the same product code (EJS) and FDA review panel - the closest regulatory comparables to K913704.
ARGEBOND 77+
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GDC-3338, DENTAL SOLDER ALLOY
K920887 · Deringer-Ney, Inc. · Mar 1992
ULTRACROWN(TM) PD ALLOY POST-SOLDER
K913860 · Dentsply Intl. · Nov 1991
PLATINUM FOIL PLATINUM MILING WAFER
K914627 · Metalor Dental USA Corp. · Nov 1991
DW238 #228-34A
K913068 · Ivoclar North America, Inc. · Oct 1991