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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alloy, Metal, Base
510(k) Number K033045
Device Name DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, DREAM LITHECAST
Applicant
American Green Dent. Mfg, Inc.
3432 E. 14th St.
Los Angeles,  CA  90023
Applicant Contact ANDREW ROWE
Correspondent
American Green Dent. Mfg, Inc.
3432 E. 14th St.
Los Angeles,  CA  90023
Correspondent Contact ANDREW ROWE
Regulation Number872.3710
Classification Product Code
EJH  
Date Received09/29/2003
Decision Date 12/23/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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