Cleared Traditional

ARGENCO Y + (K915612) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K915612 · Argen Precious Metals, Inc. · Dental device
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Jan 1994
Decision
753d
Days
Class 2
Risk

K915612 is an FDA 510(k) clearance for the ARGENCO Y +. 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 January 7, 1994 after a review of 753 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Argen Precious Metals, Inc. devices

Submission Details

510(k) Number K915612 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1991
Decision Date January 07, 1994
Days to Decision 753 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
626d slower than avg
Panel avg: 127d · This submission: 753d
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 626
Devices cleared under the same product code (EJT) and FDA review panel - the closest regulatory comparables to K915612.
ORION E ALLOY
K032316 · Dentsply Intl. · Sep 2003
ORION GX ALLOY
K032317 · Dentsply Intl. · Sep 2003
285 SL
K961352 · Argen Precious Metals, Inc. · May 1996
ARGELITE 52+
K961211 · Argen Precious Metals, Inc. · Apr 1996
ARGEDENT 40(GOLD-PALLADIUM-SILVER ALLOY FOR PORCELAIN APPLICATION)
K961285 · Argen Precious Metals, Inc. · Apr 1996
ARGISTAR 74
K954362 · Argen Precious Metals, Inc. · Oct 1995