Cleared Traditional

K972945 - AURENORM 68

K972945 is an FDA 510(k) clearance for AURENORM 68, manufactured by Aurex Precious Metal Industries (Pty)Ltd. The device is a Class 2 Dental device with product code EJS cleared through the Traditional 510(k) pathway after a 159-day FDA review.

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

FDA 510(k) Submission Details - K972945

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
Combination Product No
PCCP Authorized No
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.

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 163
Devices cleared under the same product code (EJS) and FDA review panel - the closest regulatory comparables to K972945.
D-SIGN I (R&D PROJECT DW263 #24)
K984451 · Ivoclar North America, Inc. · Jan 1999
JELFINE-52 (CODE NAME RD-0901)
K981257 · J.F. Jelenko & Co., Inc. · Aug 1998
SILCAST (CODE NAME RD-0118)
K981247 · J.F. Jelenko & Co., Inc. · Jul 1998
STABILOR HN
K973288 · Degussa Corp. · Nov 1997
VERA SOLDER
K972533 · Aalba Dent, Inc. · Sep 1997
ALFALLOY
K972534 · Aalba Dent, Inc. · Sep 1997