Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

GDC 1453 CASTING ALLOY

K-Number: K854285 · 1985-12-27

ApplicantDeringer-Ney, Inc.
Decision Date1985-12-27
Product CodeEJH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GDC 1453 CASTING ALLOY 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 1985-12-27 under 510(k) number K854285. The device is classified under product code EJH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GDC 1453 CASTING ALLOY?

GDC 1453 CASTING ALLOY is a medical device that received FDA 510(k) clearance on 1985-12-27. The listed applicant is Deringer-Ney, Inc.. The 510(k) number is K854285.

When did GDC 1453 CASTING ALLOY receive FDA 510(k) clearance?

GDC 1453 CASTING ALLOY received FDA 510(k) clearance on 1985-12-27, under 510(k) number K854285.

Who is the listed applicant for GDC 1453 CASTING ALLOY?

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 1453 CASTING ALLOY?

The FDA product code for GDC 1453 CASTING ALLOY is EJH.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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-4K925273GDC 3445K920922GDC 3367K920060DENTAL SOLDER ALLOY

View all 46 devices →

Related Devices (Code: EJH)

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.

K123929BEGOPAL+Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & COK040180CONTINUM VAalba Dent, Inc.K040179CONTINUMAalba Dent, Inc.K033356VERASOFT ESAalba Dent, Inc.K033045DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, DREAM LITHECASTAmerican Green Dent. Mfg, Inc.K032136WIROBOND CBego U.S.A.

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.

↑