Cleared Traditional

K972949 - AURELUX BIO Y85PF

K972949 is an FDA 510(k) clearance for AURELUX BIO Y85PF, 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 90-day FDA review.

K972949 · Aurex Precious Metal Industries (Pty)Ltd · Dental device
Download Printable Device Report (PDF)
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Sep 1997
Decision
90d
Days
Class 2
Risk

K972949 is an FDA 510(k) clearance for the AURELUX BIO Y85PF. 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 September 18, 1997 after a review of 90 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 Aurex Precious Metal Industries (Pty)Ltd devices

FDA 510(k) Submission Details - K972949

510(k) Number K972949 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1997
Decision Date September 18, 1997
Days to Decision 90 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
37d faster than avg
Panel avg: 127d · This submission: 90d
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 530
Devices cleared under the same product code (EJT) and FDA review panel - the closest regulatory comparables to K972949.
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
AURECAST 92
K972943 · Aurex Precious Metal Industries (Pty)Ltd · Sep 1997
HIPALLAUR 19
K972950 · Aurex Precious Metal Industries (Pty)Ltd · Sep 1997
HIPALLAUR 51
K972951 · Aurex Precious Metal Industries (Pty)Ltd · Sep 1997