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FDA 510(k)

NICKEL-BASED DENTAL CASTING ALLOY

K-Number: K820328 · 1982-03-02

ApplicantDentsply Intl.
Decision Date1982-03-02
Product CodeEJH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NICKEL-BASED DENTAL CASTING ALLOY is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 1982-03-02 under 510(k) number K820328. 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-BASED DENTAL CASTING ALLOY?

NICKEL-BASED DENTAL CASTING ALLOY is a medical device that received FDA 510(k) clearance on 1982-03-02. The listed applicant is Dentsply Intl.. The 510(k) number is K820328.

When did NICKEL-BASED DENTAL CASTING ALLOY receive FDA 510(k) clearance?

NICKEL-BASED DENTAL CASTING ALLOY received FDA 510(k) clearance on 1982-03-02, under 510(k) number K820328.

Who is the listed applicant for NICKEL-BASED DENTAL CASTING ALLOY?

The FDA 510(k) record lists Dentsply Intl. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NICKEL-BASED DENTAL CASTING ALLOY?

The FDA product code for NICKEL-BASED DENTAL CASTING ALLOY is EJH.

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Related Devices (Code: EJH)

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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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