FDA 510(k)

GDC 1448 DEVELOPMENT NAME

K-Number: K833596 · 1983-12-29

Decision Date1983-12-29

Product CodeEJS

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

GDC 1448 DEVELOPMENT NAME 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 1983-12-29 under 510(k) number K833596. 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 1448 DEVELOPMENT NAME?

GDC 1448 DEVELOPMENT NAME is a medical device that received FDA 510(k) clearance on 1983-12-29. The listed applicant is Deringer-Ney, Inc.. The 510(k) number is K833596.

When did GDC 1448 DEVELOPMENT NAME receive FDA 510(k) clearance?

GDC 1448 DEVELOPMENT NAME received FDA 510(k) clearance on 1983-12-29, under 510(k) number K833596.

Who is the listed applicant for GDC 1448 DEVELOPMENT NAME?

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 1448 DEVELOPMENT NAME?

The FDA product code for GDC 1448 DEVELOPMENT NAME is EJS.

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Other records listing Deringer-Ney, Inc. as applicant

K933178GDC 3509 K930482DENTAL CASTING ALLOY, MODIFICATION - PF-3 K930481DENTAL CASTING ALLOY MODIFICATION-PF-4 K925273GDC 3445 K920922GDC 3367 K920060DENTAL SOLDER ALLOY

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Related Devices (Code: EJS)

K041433BRIGHT GOLD XHIvoclar Vivadent, Inc.K040436SIMIDUR SUPERIORWieland Dental + Technik GmbH & Co. KG K022252STERNGOLD 1, MODEL 1127781Sterngold K022469ECO E4Wieland Dental + Technik GmbH & Co. KG K021367STERNGOLD 66, MODEL #1180230Sterngold K020195SIMIDUR 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.