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FDA 510(k)

HERAENIUM CA

K-Number: K851515 · 1985-09-23

ApplicantHeraeus Dental Gold Corp.
Decision Date1985-09-23
Product CodeEJH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HERAENIUM CA is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Dental Gold Corp.. It received FDA 510(k) clearance on 1985-09-23 under 510(k) number K851515. 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 HERAENIUM CA?

HERAENIUM CA is a medical device that received FDA 510(k) clearance on 1985-09-23. The listed applicant is Heraeus Dental Gold Corp.. The 510(k) number is K851515.

When did HERAENIUM CA receive FDA 510(k) clearance?

HERAENIUM CA received FDA 510(k) clearance on 1985-09-23, under 510(k) number K851515.

Who is the listed applicant for HERAENIUM CA?

The FDA 510(k) record lists Heraeus Dental Gold Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HERAENIUM CA?

The FDA product code for HERAENIUM CA 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.

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Other records listing Heraeus Dental Gold Corp. 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.

K851872BLENGOLD SPECIALK851648HERACOR SYSTEM HERACOR PLATINUM FOIL, BLENDGOLD NE

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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