510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K972945Substantially Equivalent

Aurenorm 68

Aurex Precious Metal Industries (Pty)Ltd, Edenvale, ZA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K972945 is the FDA 510(k) clearance record for AURENORM 68, a class II device, cleared for Aurex Precious Metal Industries (Pty)Ltd on under FDA product code EJS (Alloy, Other Noble Metal). FDA records list 19 510(k) clearances for Aurex Precious Metal Industries (Pty)Ltd, from to . As of , FDA records show no recalls naming K972945.

Clearance record

Decision date
Received
(159 days to decision)
Product code
EJS Alloy, Other Noble Metal
Regulation
21 CFR 872.3060
Device class
Class II
Review panel
Dental
Applicant
Aurex Precious Metal Industries (Pty)Ltd P.O. Box 509, Edenvale, ZA
510(k) summary
Summary
Third party review
No

Clearances, product code EJS

Trailing 12 months

FDA records hold no clearances under product code EJS in the trailing twelve months.

FDA records show no clearances under product code EJS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EJS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260