Cleared Traditional

K972939 - AURECAST BIO 59PF

K972939 is an FDA 510(k) clearance for AURECAST BIO 59PF, 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 67-day FDA review.

K972939 · Aurex Precious Metal Industries (Pty)Ltd · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
67d
Days
Class 2
Risk

K972939 is an FDA 510(k) clearance for the AURECAST BIO 59PF. 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 August 26, 1997 after a review of 67 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Aurex Precious Metal Industries (Pty)Ltd devices

FDA 510(k) Submission Details - K972939

510(k) Number K972939 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1997
Decision Date August 26, 1997
Days to Decision 67 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
60d faster than avg
Panel avg: 127d · This submission: 67d
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 K972939.
AURECAST 74
K972941 · Aurex Precious Metal Industries (Pty)Ltd · Aug 1997
AURECAST 83
K972942 · Aurex Precious Metal Industries (Pty)Ltd · Aug 1997
AURECAST GF
K972319 · Aurex Precious Metal Industries (Pty)Ltd · Aug 1997
AURECAST BIO 69PF
K972940 · Aurex Precious Metal Industries (Pty)Ltd · Aug 1997
AURECAST 2
K972936 · Aurex Precious Metal Industries (Pty)Ltd · Aug 1997
AURECAST 4
K972937 · Aurex Precious Metal Industries (Pty)Ltd · Aug 1997