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FDA 510(k)

AURENORM 75 KF

K-Number: K001482 · 2000-06-23

ApplicantAurex SA (Pty) , Ltd.
Decision Date2000-06-23
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AURENORM 75 KF is the device name listed in this FDA 510(k) record. The listed applicant is Aurex SA (Pty) , Ltd.. It received FDA 510(k) clearance on 2000-06-23 under 510(k) number K001482. The device is classified under product code EJT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AURENORM 75 KF?

AURENORM 75 KF is a medical device that received FDA 510(k) clearance on 2000-06-23. The listed applicant is Aurex SA (Pty) , Ltd.. The 510(k) number is K001482.

When did AURENORM 75 KF receive FDA 510(k) clearance?

AURENORM 75 KF received FDA 510(k) clearance on 2000-06-23, under 510(k) number K001482.

Who is the listed applicant for AURENORM 75 KF?

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

What is the FDA product code for AURENORM 75 KF?

The FDA product code for AURENORM 75 KF is EJT.

Related Clinical Trials

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Other records listing Aurex SA (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.

K001481PALCERAM 49K001480AURECAST 40 BK001479PALCERAM 53K001477AURELUX Y 84 PREMIUMK001478AURECAST SUPER INLAY

Related Devices (Code: EJT)

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.

K052463PROMETAL HN86Prometal TechnologiesK041378BIO 60Kodent, Inc.K040672PORTA REFLEXWieland Dental + Technik GmbH & Co. KGK040524PORTA SOLDER 1090 WWieland Dental + Technik GmbH & Co. KGK040043NDX-40 ALLOYHeraeus Kulzer, Inc.K034049HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, B AND A; BIO HERANORMHeraeus Kulzer,GmbH

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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