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FDA 510(k)

TRINDIUM-DENTAL MATERIAL

K-Number: K850084 · 1985-07-08

ApplicantTrindium Corp. of America
Decision Date1985-07-08
Product CodeEJH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TRINDIUM-DENTAL MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Trindium Corp. of America. It received FDA 510(k) clearance on 1985-07-08 under 510(k) number K850084. 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 TRINDIUM-DENTAL MATERIAL?

TRINDIUM-DENTAL MATERIAL is a medical device that received FDA 510(k) clearance on 1985-07-08. The listed applicant is Trindium Corp. of America. The 510(k) number is K850084.

When did TRINDIUM-DENTAL MATERIAL receive FDA 510(k) clearance?

TRINDIUM-DENTAL MATERIAL received FDA 510(k) clearance on 1985-07-08, under 510(k) number K850084.

Who is the listed applicant for TRINDIUM-DENTAL MATERIAL?

The FDA 510(k) record lists Trindium Corp. of America as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRINDIUM-DENTAL MATERIAL?

The FDA product code for TRINDIUM-DENTAL MATERIAL is EJH.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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