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FDA 510(k)

GDC 3445

K-Number: K925273 · 1992-12-21

ApplicantDeringer-Ney, Inc.
Decision Date1992-12-21
Product CodeEJS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GDC 3445 is the device name listed in this FDA 510(k) record. The listed applicant is Deringer-Ney, Inc.. It received FDA 510(k) clearance on 1992-12-21 under 510(k) number K925273. 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 GDC 3445?

GDC 3445 is a medical device that received FDA 510(k) clearance on 1992-12-21. The listed applicant is Deringer-Ney, Inc.. The 510(k) number is K925273.

When did GDC 3445 receive FDA 510(k) clearance?

GDC 3445 received FDA 510(k) clearance on 1992-12-21, under 510(k) number K925273.

Who is the listed applicant for GDC 3445?

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

What is the FDA product code for GDC 3445?

The FDA product code for GDC 3445 is EJS.

Other records listing Deringer-Ney, 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.

K933178GDC 3509K930482DENTAL CASTING ALLOY, MODIFICATION - PF-3K930481DENTAL CASTING ALLOY MODIFICATION-PF-4K920922GDC 3367K920060DENTAL SOLDER ALLOYK920887GDC-3338, DENTAL SOLDER ALLOY

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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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