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FDA 510(k)

SOLDER 585

K-Number: K964707 · 1996-12-16

ApplicantGateway Alloys, Inc.
Decision Date1996-12-16
Product CodeEJS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SOLDER 585 is the device name listed in this FDA 510(k) record. The listed applicant is Gateway Alloys, Inc.. It received FDA 510(k) clearance on 1996-12-16 under 510(k) number K964707. 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 SOLDER 585?

SOLDER 585 is a medical device that received FDA 510(k) clearance on 1996-12-16. The listed applicant is Gateway Alloys, Inc.. The 510(k) number is K964707.

When did SOLDER 585 receive FDA 510(k) clearance?

SOLDER 585 received FDA 510(k) clearance on 1996-12-16, under 510(k) number K964707.

Who is the listed applicant for SOLDER 585?

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

What is the FDA product code for SOLDER 585?

The FDA product code for SOLDER 585 is EJS.

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Other records listing Gateway Alloys, 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.

K011659GPW-SFK011661CONCORD 88K011628CONCORD 82K011626CONCORD 72K964940TAOS 28K964941EL DORADO 40

View all 31 devices →

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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