Cleared Traditional

K001478 - AURECAST SUPER INLAY

K001478 is an FDA 510(k) clearance for AURECAST SUPER INLAY, manufactured by Aurex SA (Pty) , Ltd.. The device is a Class 2 Dental device with product code EJT cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K001478 · Aurex SA (Pty) , Ltd. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
40d
Days
Class 2
Risk

K001478 is an FDA 510(k) clearance for the AURECAST SUPER INLAY. Classified as Alloy, Gold-based Noble Metal (product code EJT), Class II - Special Controls.

Submitted by Aurex SA (Pty) , Ltd. (Edenvale, Gauteng, ZA). The FDA issued a Cleared decision on June 20, 2000 after a review of 40 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.

FDA 510(k) Submission Details - K001478

510(k) Number K001478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2000
Decision Date June 20, 2000
Days to Decision 40 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
88d faster than avg
Panel avg: 128d · This submission: 40d
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 626
Devices cleared under the same product code (EJT) and FDA review panel - the closest regulatory comparables to K001478.
PALCERAM 53
K001479 · Aurex SA (Pty) , Ltd. · Jun 2000
AURECAST 40 B
K001480 · Aurex SA (Pty) , Ltd. · Jun 2000
AURELUX Y 84 PREMIUM
K001477 · Aurex SA (Pty) , Ltd. · Jun 2000
AGC-GOLD ELECTROLYTE FOR AGC-MICRO, AGC-GOLD ELECTROLYTE FOR AGC-SPEED, AGC-GOLDBONDER, AGC GLAVANOGOLD
K001041 · Wieland Edelmetalle GmbH & Co. · May 2000
ALLROUND 55 LF
K001260 · J.F. Jelenko & Co., Inc. · May 2000
JEL BIOS 90 (CODE NAME RD-2401)
K001196 · J.F. Jelenko & Co., Inc. · May 2000
K001478 · AURECAST SUPER INLAY
Download PDF FDA Summary Aurex SA (Pty) , Ltd.