Cleared Traditional

V-SUPERGOLD (K911531) - FDA 510(k) Clearance

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

K911531 · Metalor Dental USA Corp. · Dental device
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Apr 1991
Decision
28d
Days
Class 2
Risk

K911531 is an FDA 510(k) clearance for the V-SUPERGOLD. Classified as Alloy, Gold-based Noble Metal (product code EJT), Class II - Special Controls.

Submitted by Metalor Dental USA Corp. (Rockville Centre, US). The FDA issued a Cleared decision on April 29, 1991 after a review of 28 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 Metalor Dental USA Corp. devices

Submission Details

510(k) Number K911531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1991
Decision Date April 29, 1991
Days to Decision 28 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 127d · This submission: 28d
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 208
Devices cleared under the same product code (EJT) and FDA review panel - the closest regulatory comparables to K911531.
ARGELITE 55
K931475 · Argen Precious Metals, Inc. · Jul 1993
ARGENCO 75M
K924241 · Argen Precious Metals, Inc. · Nov 1992
ULTRACROWN(TM) PRE-SOLDER
K914186 · Dentsply Intl. · Dec 1991
TYPE III DENTAL GOLD ALLOY FOR CROWN & BRIDGE APP.
K905761 · Argen Precious Metals, Inc. · Jan 1991
ARGENCO 52HN
K905811 · Argen Precious Metals, Inc. · Jan 1991
ARGENCO 19
K904437 · Argen Precious Metals, Inc. · Nov 1990