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FDA 510(k)

ARGELITE A

K-Number: K934773 · 1993-12-10

ApplicantArgen Precious Metals, Inc.
Decision Date1993-12-10
Product CodeEJS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ARGELITE A 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 1993-12-10 under 510(k) number K934773. 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 ARGELITE A?

ARGELITE A is a medical device that received FDA 510(k) clearance on 1993-12-10. The listed applicant is Argen Precious Metals, Inc.. The 510(k) number is K934773.

When did ARGELITE A receive FDA 510(k) clearance?

ARGELITE A received FDA 510(k) clearance on 1993-12-10, under 510(k) number K934773.

Who is the listed applicant for ARGELITE A?

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 ARGELITE A?

The FDA product code for ARGELITE A is EJS.

Related Clinical Trials

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.

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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: 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 #1180230SterngoldK020195SIMIDUR S1SWieland 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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