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FDA 510(k)

AUROLITE 54+2

K-Number: K940435 · 1994-03-07

ApplicantArgen Precious Metals, Inc.
Decision Date1994-03-07
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AUROLITE 54+2 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 1994-03-07 under 510(k) number K940435. 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 AUROLITE 54+2?

AUROLITE 54+2 is a medical device that received FDA 510(k) clearance on 1994-03-07. The listed applicant is Argen Precious Metals, Inc.. The 510(k) number is K940435.

When did AUROLITE 54+2 receive FDA 510(k) clearance?

AUROLITE 54+2 received FDA 510(k) clearance on 1994-03-07, under 510(k) number K940435.

Who is the listed applicant for AUROLITE 54+2?

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 AUROLITE 54+2?

The FDA product code for AUROLITE 54+2 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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