Cleared Traditional

K972946 - AURELUX 77

K972946 is an FDA 510(k) clearance for AURELUX 77, manufactured by Aurex Precious Metal Industries (Pty)Ltd. The device is a Class 2 Dental device with product code EJT cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K972946 · Aurex Precious Metal Industries (Pty)Ltd · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 1997
Decision
182d
Days
Class 2
Risk

K972946 is an FDA 510(k) clearance for the AURELUX 77. Classified as Alloy, Gold-based Noble Metal (product code EJT), Class II - Special Controls.

Submitted by Aurex Precious Metal Industries (Pty)Ltd (Edenvale, ZA). The FDA issued a Cleared decision on December 19, 1997 after a review of 182 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.

FDA 510(k) Submission Details - K972946

510(k) Number K972946 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1997
Decision Date December 19, 1997
Days to Decision 182 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
54d slower than avg
Panel avg: 128d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJT Device Classification - Class 2, Special Controls

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 623
Devices cleared under the same product code (EJT) and FDA review panel - the closest regulatory comparables to K972946.
BIOGOLD PLUS DENTAL ALLOY
K980660 · European Dental Imports, Inc. · Apr 1998
CARRARA PDF, CARRARA H, CARRARA R
K980597 · European Dental Imports, Inc. · Mar 1998
PROGOLD ELECTROCOPING SYSTEM
K980613 · Micro Dental Laboratories · Mar 1998
AUROFILM 2000
K973372 · Metalor Dental USA Corp. · Nov 1997
PROSPECTOR PLUS (CODE NAME : RD-0508)
K973881 · J.F. Jelenko & Co., Inc. · Nov 1997
PORS ON LITE
K972910 · Degussa Corp. · Oct 1997
K972946 · AURELUX 77
Download PDF FDA Summary Aurex Precious Metal …