Skip to content

Dream Bond, Dreamcast Chrome, Dreamcast V, Dream Flexicast, Dream Lithecast

by American Green Dent. Mfg, Inc.

510(k) K033045

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK033045 Date23 Dec 2003ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
EJH
Device Class
Class II
Regulation
21 CFR Part 872.3710
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a base metal alloy used in dental applications. It is classified as Alloy, Metal, Base under regulation number 872.3710 and is intended for use by dental laboratory technicians in the fabrication of metal-ceramic restorations or removable dental appliances.

The device is supplied as a dental casting alloy and is used in dental laboratory settings. It has received FDA 510(k) clearance under K033045 with product code EJH, and is classified as a Class II medical device. The clearance type is traditional, and the decision was substantially equivalent (SESE).

Other devices from American Green Dent. Mfg, Inc.

Questions

AI-generated answers, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, DREAM LITHECAST device used for?

    This device is a base metal alloy intended for use by dental laboratory technicians in the fabrication of metal-ceramic restorations or removable dental appliances. It is supplied as a dental casting alloy and used in dental laboratory settings for these specific applications.

  • How is the DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, DREAM LITHECAST supplied and what is its form?

    The device is supplied as a dental casting alloy, meaning it is provided in a form suitable for melting and casting in dental laboratory processes to create metal frameworks for restorations or appliances.

  • What regulatory clearance does the DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, DREAM LITHECAST have?

    The device has received FDA 510(k) clearance under submission number K033045, with product code EJH, and is classified as a Class II medical device under regulation number 872.3710. The clearance was granted as substantially equivalent through a traditional review process.