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FDA 510(k)

THERMABOND SUPERCAST NP OR THERMABOND SUPERCAST

K-Number: K911821 · 1991-05-30

ApplicantDentecon, Inc.
Decision Date1991-05-30
Product CodeEJH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

THERMABOND SUPERCAST NP OR THERMABOND SUPERCAST is the device name listed in this FDA 510(k) record. The listed applicant is Dentecon, Inc.. It received FDA 510(k) clearance on 1991-05-30 under 510(k) number K911821. 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 THERMABOND SUPERCAST NP OR THERMABOND SUPERCAST?

THERMABOND SUPERCAST NP OR THERMABOND SUPERCAST is a medical device that received FDA 510(k) clearance on 1991-05-30. The listed applicant is Dentecon, Inc.. The 510(k) number is K911821.

When did THERMABOND SUPERCAST NP OR THERMABOND SUPERCAST receive FDA 510(k) clearance?

THERMABOND SUPERCAST NP OR THERMABOND SUPERCAST received FDA 510(k) clearance on 1991-05-30, under 510(k) number K911821.

Who is the listed applicant for THERMABOND SUPERCAST NP OR THERMABOND SUPERCAST?

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

What is the FDA product code for THERMABOND SUPERCAST NP OR THERMABOND SUPERCAST?

The FDA product code for THERMABOND SUPERCAST NP OR THERMABOND SUPERCAST 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 Dentecon, 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.

K926378THERMABOND V

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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