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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Polishing, Abrasive, Oral Cavity
510(k) Number K033785
Device Name PROACTIVE CARE PROPHYLAXIS PASTE WITH FLUORIDE
Applicant
Discus Dental, Inc.
8550 Higuera St.
Culver City,  CA  90232
Applicant Contact VIVIAN LAI
Correspondent
Discus Dental, Inc.
8550 Higuera St.
Culver City,  CA  90232
Correspondent Contact VIVIAN LAI
Regulation Number872.6030
Classification Product Code
EJR  
Date Received12/04/2003
Decision Date 06/18/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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