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FDA 510(k)

SUPREMCAST V

K-Number: K001383 · 2000-07-05

ApplicantAmerican Dent-All, Inc.
Decision Date2000-07-05
Product CodeEJH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SUPREMCAST V is the device name listed in this FDA 510(k) record. The listed applicant is American Dent-All, Inc.. It received FDA 510(k) clearance on 2000-07-05 under 510(k) number K001383. 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 SUPREMCAST V?

SUPREMCAST V is a medical device that received FDA 510(k) clearance on 2000-07-05. The listed applicant is American Dent-All, Inc.. The 510(k) number is K001383.

When did SUPREMCAST V receive FDA 510(k) clearance?

SUPREMCAST V received FDA 510(k) clearance on 2000-07-05, under 510(k) number K001383.

Who is the listed applicant for SUPREMCAST V?

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

What is the FDA product code for SUPREMCAST V?

The FDA product code for SUPREMCAST V 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 American Dent-All, 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.

K030161SUPERBONDK011706FLEXICAST PRIMEK011705SUPREMCASTK003509FLEXICAST

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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