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FDA 510(k)

AURELUX Y 84 PREMIUM

K-Number: K001477 · 2000-06-20

ApplicantAurex SA (Pty) , Ltd.
Decision Date2000-06-20
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AURELUX Y 84 PREMIUM 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 2000-06-20 under 510(k) number K001477. 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 AURELUX Y 84 PREMIUM?

AURELUX Y 84 PREMIUM is a medical device that received FDA 510(k) clearance on 2000-06-20. The listed applicant is Aurex SA (Pty) , Ltd.. The 510(k) number is K001477.

When did AURELUX Y 84 PREMIUM receive FDA 510(k) clearance?

AURELUX Y 84 PREMIUM received FDA 510(k) clearance on 2000-06-20, under 510(k) number K001477.

Who is the listed applicant for AURELUX Y 84 PREMIUM?

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 AURELUX Y 84 PREMIUM?

The FDA product code for AURELUX Y 84 PREMIUM is EJT.

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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.

K001482AURENORM 75 KFK001481PALCERAM 49K001480AURECAST 40 BK001479PALCERAM 53K001478AURECAST 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

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

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