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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Scaler, Ultrasonic
510(k) Number K033044
Device Name DREAM CLEANSE S SCALER, DREAM COMPACT S SCALER
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 Number872.4850
Classification Product Code
ELC  
Date Received09/29/2003
Decision Date 12/21/2004
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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