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FDA 510(k)

DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, DREAM LITHECAST

K-Number: K033045 · 2003-12-23

ApplicantAmerican Green Dent. Mfg, Inc.
Decision Date2003-12-23
Product CodeEJH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, DREAM LITHECAST is the device name listed in this FDA 510(k) record. The listed applicant is American Green Dent. Mfg, Inc.. It received FDA 510(k) clearance on 2003-12-23 under 510(k) number K033045. 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 DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, DREAM LITHECAST?

DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, DREAM LITHECAST is a medical device that received FDA 510(k) clearance on 2003-12-23. The listed applicant is American Green Dent. Mfg, Inc.. The 510(k) number is K033045.

When did DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, DREAM LITHECAST receive FDA 510(k) clearance?

DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, DREAM LITHECAST received FDA 510(k) clearance on 2003-12-23, under 510(k) number K033045.

Who is the listed applicant for DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, DREAM LITHECAST?

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

What is the FDA product code for DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, DREAM LITHECAST?

The FDA product code for DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, DREAM LITHECAST 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 Green Dent. Mfg, 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.

K033044DREAM CLEANSE S SCALER, DREAM COMPACT S SCALER

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.K032136WIROBOND CBego U.S.A.K031627NANO-TICROWNNano-Write Corp.

Official Source

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