Cleared Traditional

K001482 - AURENORM 75 KF

K001482 is an FDA 510(k) clearance for AURENORM 75 KF, 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 43-day FDA review.

K001482 · Aurex SA (Pty) , Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
43d
Days
Class 2
Risk

K001482 is an FDA 510(k) clearance for the AURENORM 75 KF. 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 23, 2000 after a review of 43 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 SA (Pty) , Ltd. devices

FDA 510(k) Submission Details - K001482

510(k) Number K001482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2000
Decision Date June 23, 2000
Days to Decision 43 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 127d · This submission: 43d
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.

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All 552
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