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FDA 510(k)

NICKEL,20% CHROMIUM PORCELAIN FUSED TO METAL ALLOY

K-Number: K862417 · 1986-07-03

ApplicantAustenal Dental, Inc.
Decision Date1986-07-03
Product CodeEJH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NICKEL,20% CHROMIUM PORCELAIN FUSED TO METAL ALLOY is the device name listed in this FDA 510(k) record. The listed applicant is Austenal Dental, Inc.. It received FDA 510(k) clearance on 1986-07-03 under 510(k) number K862417. 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 NICKEL,20% CHROMIUM PORCELAIN FUSED TO METAL ALLOY?

NICKEL,20% CHROMIUM PORCELAIN FUSED TO METAL ALLOY is a medical device that received FDA 510(k) clearance on 1986-07-03. The listed applicant is Austenal Dental, Inc.. The 510(k) number is K862417.

When did NICKEL,20% CHROMIUM PORCELAIN FUSED TO METAL ALLOY receive FDA 510(k) clearance?

NICKEL,20% CHROMIUM PORCELAIN FUSED TO METAL ALLOY received FDA 510(k) clearance on 1986-07-03, under 510(k) number K862417.

Who is the listed applicant for NICKEL,20% CHROMIUM PORCELAIN FUSED TO METAL ALLOY?

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

What is the FDA product code for NICKEL,20% CHROMIUM PORCELAIN FUSED TO METAL ALLOY?

The FDA product code for NICKEL,20% CHROMIUM PORCELAIN FUSED TO METAL ALLOY is EJH.

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Other records listing Austenal Dental, 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.

K890713OVERDENTURE - STUD ATTACHMENTK883799BASE, DENTURE, RELINING, REPAIRING, REBASING,RESINK880875VITALLIUM EQUIPOISE ALLOYK871849LIGHT CURE DENTURE GLAZEK872746VITALLIUM WIREK863630AUSTENAL ACUPAC 20 DENTURE BASE MATERIAL

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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.

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