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FDA 510(k)

AURIUM D16

K-Number: K941097 · 1994-04-29

ApplicantArgen Precious Metals, Inc.
Decision Date1994-04-29
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AURIUM D16 is the device name listed in this FDA 510(k) record. The listed applicant is Argen Precious Metals, Inc.. It received FDA 510(k) clearance on 1994-04-29 under 510(k) number K941097. 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 AURIUM D16?

AURIUM D16 is a medical device that received FDA 510(k) clearance on 1994-04-29. The listed applicant is Argen Precious Metals, Inc.. The 510(k) number is K941097.

When did AURIUM D16 receive FDA 510(k) clearance?

AURIUM D16 received FDA 510(k) clearance on 1994-04-29, under 510(k) number K941097.

Who is the listed applicant for AURIUM D16?

The FDA 510(k) record lists Argen Precious Metals, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AURIUM D16?

The FDA product code for AURIUM D16 is EJT.

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Other records listing Argen Precious Metals, Inc. 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.

K965216ARGI-SATIN OR OPTI0-STARK961352285 SLK961211ARGELITE 52+K961285ARGEDENT 40(GOLD-PALLADIUM-SILVER ALLOY FOR PORCELAIN APPLICATION)K954362ARGISTAR 74K954360ARGESOL 600

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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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