Cleared Traditional

K972955 - PALCERAM 56

K972955 is an FDA 510(k) clearance for PALCERAM 56, 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 77-day FDA review.

K972955 · Aurex Precious Metal Industries (Pty)Ltd · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1997
Decision
77d
Days
Class 2
Risk

K972955 is an FDA 510(k) clearance for the PALCERAM 56. 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 5, 1997 after a review of 77 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 - K972955

510(k) Number K972955 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1997
Decision Date September 05, 1997
Days to Decision 77 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
50d faster than avg
Panel avg: 127d · This submission: 77d
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 K972955.
AUREBOND 51
K972952 · Aurex Precious Metal Industries (Pty)Ltd · Sep 1997
PALAUREX 76KF
K972953 · Aurex Precious Metal Industries (Pty)Ltd · Sep 1997
PALAUREX 78
K972954 · Aurex Precious Metal Industries (Pty)Ltd · Sep 1997
PALCERAM 82SF
K972956 · Aurex Precious Metal Industries (Pty)Ltd · Sep 1997
AURECAST 74
K972941 · Aurex Precious Metal Industries (Pty)Ltd · Aug 1997
AURECAST 83
K972942 · Aurex Precious Metal Industries (Pty)Ltd · Aug 1997