Cleared Traditional

K915165 - ARGEBOND 77+

K915165 is an FDA 510(k) clearance for ARGEBOND 77+, 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 158-day FDA review.

K915165 · Argen Precious Metals, Inc. · Dental device
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Apr 1992
Decision
158d
Days
Class 2
Risk

K915165 is an FDA 510(k) clearance for the ARGEBOND 77+. 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 April 21, 1992 after a review of 158 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Argen Precious Metals, Inc. devices

FDA 510(k) Submission Details - K915165

510(k) Number K915165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1991
Decision Date April 21, 1992
Days to Decision 158 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
31d slower than avg
Panel avg: 127d · This submission: 158d
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 K915165.
DEVA PLUS
K921419 · Degussa AG · May 1992
DEGUBOND PLUS
K921445 · Degussa AG · May 1992
GDC 3367
K920922 · Deringer-Ney, Inc. · May 1992
DW 215-12A ALLOY FOR FORCELAIN FUSED TO METAL
K920613 · Ivoclar North America, Inc. · Apr 1992
GDC-3338, DENTAL SOLDER ALLOY
K920887 · Deringer-Ney, Inc. · Mar 1992
ARGEBOND 80
K913704 · Argen Precious Metals, Inc. · Nov 1991