Cleared Traditional

AURENORM 68 (K972945) - FDA 510(k) Clearance

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

K972945 · Aurex Precious Metal Industries (Pty)Ltd · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1997
Decision
159d
Days
Class 2
Risk

K972945 is an FDA 510(k) clearance for the AURENORM 68. Classified as Alloy, Other Noble Metal (product code EJS), Class II - Special Controls.

Submitted by Aurex Precious Metal Industries (Pty)Ltd (Edenvale, ZA). The FDA issued a Cleared decision on November 26, 1997 after a review of 159 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 Aurex Precious Metal Industries (Pty)Ltd devices

Submission Details

510(k) Number K972945 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1997
Decision Date November 26, 1997
Days to Decision 159 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
32d slower than avg
Panel avg: 127d · This submission: 159d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 24
Devices cleared under the same product code (EJS) and FDA review panel - the closest regulatory comparables to K972945.
ARGELITE A
K934773 · Argen Precious Metals, Inc. · Dec 1993
ARGEBOND 77+
K915165 · Argen Precious Metals, Inc. · Apr 1992
ARGEBOND 80
K913704 · Argen Precious Metals, Inc. · Nov 1991
ULTRACROWN(TM) PD ALLOY POST-SOLDER
K913860 · Dentsply Intl. · Nov 1991
ULTRACROWN(TM) PD DENTAL ALLOY
K913232 · Dentsply Intl. · Sep 1991
MAXIBOND
K911757 · Argen Precious Metals, Inc. · Jun 1991