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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 K040661
Device Name RADENT PROPHY PASTE
Applicant
Pascal Co., Inc.
2929 NE Northup Way
Bellevue,  WA  98004
Applicant Contact VINCENT M TENTARELLI
Correspondent
Pascal Co., Inc.
2929 NE Northup Way
Bellevue,  WA  98004
Correspondent Contact VINCENT M TENTARELLI
Regulation Number872.6030
Classification Product Code
EJR  
Date Received03/12/2004
Decision Date 06/09/2004
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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