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FDA 510(k)

GDC 3509

K-Number: K933178 · 1993-10-14

ApplicantDeringer-Ney, Inc.
Decision Date1993-10-14
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GDC 3509 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 1993-10-14 under 510(k) number K933178. The device is classified under product code EJT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GDC 3509?

GDC 3509 is a medical device that received FDA 510(k) clearance on 1993-10-14. The listed applicant is Deringer-Ney, Inc.. The 510(k) number is K933178.

When did GDC 3509 receive FDA 510(k) clearance?

GDC 3509 received FDA 510(k) clearance on 1993-10-14, under 510(k) number K933178.

Who is the listed applicant for GDC 3509?

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 3509?

The FDA product code for GDC 3509 is EJT.

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.

K930481DENTAL CASTING ALLOY MODIFICATION-PF-4K930482DENTAL CASTING ALLOY, MODIFICATION - PF-3K925273GDC 3445K920922GDC 3367K920060DENTAL SOLDER ALLOYK920887GDC-3338, DENTAL SOLDER ALLOY

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Related Devices (Code: EJT)

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.

K052463PROMETAL HN86Prometal TechnologiesK041378BIO 60Kodent, Inc.K040672PORTA REFLEXWieland Dental + Technik GmbH & Co. KGK040524PORTA SOLDER 1090 WWieland Dental + Technik GmbH & Co. KGK040043NDX-40 ALLOYHeraeus Kulzer, Inc.K034049HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, B AND A; BIO HERANORMHeraeus Kulzer,GmbH

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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