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FDA 510(k)

ARGEBOND 80

K-Number: K913704 · 1991-11-13

ApplicantArgen Precious Metals, Inc.
Decision Date1991-11-13
Product CodeEJS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ARGEBOND 80 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 1991-11-13 under 510(k) number K913704. 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 ARGEBOND 80?

ARGEBOND 80 is a medical device that received FDA 510(k) clearance on 1991-11-13. The listed applicant is Argen Precious Metals, Inc.. The 510(k) number is K913704.

When did ARGEBOND 80 receive FDA 510(k) clearance?

ARGEBOND 80 received FDA 510(k) clearance on 1991-11-13, under 510(k) number K913704.

Who is the listed applicant for ARGEBOND 80?

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 ARGEBOND 80?

The FDA product code for ARGEBOND 80 is EJS.

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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 74K954359SILFREE 80SF+

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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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