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FDA 510(k)

AURENORM 68

K-Number: K972945 · 1997-11-26

ApplicantAurex Precious Metal Industries (Pty)Ltd
Decision Date1997-11-26
Product CodeEJS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AURENORM 68 is the device name listed in this FDA 510(k) record. The listed applicant is Aurex Precious Metal Industries (Pty)Ltd. It received FDA 510(k) clearance on 1997-11-26 under 510(k) number K972945. The device is classified under product code EJS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AURENORM 68?

AURENORM 68 is a medical device that received FDA 510(k) clearance on 1997-11-26. The listed applicant is Aurex Precious Metal Industries (Pty)Ltd. The 510(k) number is K972945.

When did AURENORM 68 receive FDA 510(k) clearance?

AURENORM 68 received FDA 510(k) clearance on 1997-11-26, under 510(k) number K972945.

Who is the listed applicant for AURENORM 68?

The FDA 510(k) record lists Aurex Precious Metal Industries (Pty)Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AURENORM 68?

The FDA product code for AURENORM 68 is EJS.

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Other records listing Aurex Precious Metal Industries (Pty)Ltd as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K972946AURELUX 77K972949AURELUX BIO Y85PFK972943AURECAST 92K972954PALAUREX 78K972953PALAUREX 76KFK972956PALCERAM 82SF

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Related Devices (Code: EJS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K041433BRIGHT GOLD XHIvoclar Vivadent, Inc.K040436SIMIDUR SUPERIORWieland Dental + Technik GmbH & Co. KGK022252STERNGOLD 1, MODEL 1127781SterngoldK022469ECO E4Wieland Dental + Technik GmbH & Co. KGK021367STERNGOLD 66, MODEL #1180230SterngoldK020194SIMIDUR KF PLUSWieland Dental + Technik GmbH & Co. KG

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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