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FDA 510(k)

FLEXICAST PRIME

K-Number: K011706 · 2001-08-06

ApplicantAmerican Dent-All, Inc.
Decision Date2001-08-06
Product CodeEJH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FLEXICAST PRIME 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 2001-08-06 under 510(k) number K011706. 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 FLEXICAST PRIME?

FLEXICAST PRIME is a medical device that received FDA 510(k) clearance on 2001-08-06. The listed applicant is American Dent-All, Inc.. The 510(k) number is K011706.

When did FLEXICAST PRIME receive FDA 510(k) clearance?

FLEXICAST PRIME received FDA 510(k) clearance on 2001-08-06, under 510(k) number K011706.

Who is the listed applicant for FLEXICAST PRIME?

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 FLEXICAST PRIME?

The FDA product code for FLEXICAST PRIME 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.

K030161SUPERBONDK011705SUPREMCASTK003509FLEXICASTK001383SUPREMCAST 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

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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