Cleared Traditional

AUROPAL, ORDER-NO.: 2101 (K012839) - FDA 510(k) Clearance

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

K012839 · Wieland Edelmetalle GmbH & Co. · Dental device
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Dec 2001
Decision
130d
Days
Class 2
Risk

K012839 is an FDA 510(k) clearance for the AUROPAL, ORDER-NO.: 2101. Classified as Alloy, Gold-based Noble Metal (product code EJT), Class II - Special Controls.

Submitted by Wieland Edelmetalle GmbH & Co. (D-75179 Pforzheim, DE). The FDA issued a Cleared decision on December 31, 2001 after a review of 130 days - within the typical 510(k) review window.

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 Wieland Edelmetalle GmbH & Co. devices

Submission Details

510(k) Number K012839 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2001
Decision Date December 31, 2001
Days to Decision 130 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 127d · This submission: 130d
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 K012839.
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