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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 K033449
Device Name PRO-DENTEC DOUBLE-PRO PROPHYLAXIS PASTE WITH FLUOIDE FAMILY OF DEVICES
Applicant
Professional Dental Technologies Therapeutics, Inc.
500 White Dr.
Batesville,  AR  72501
Applicant Contact JOANN UNDERWOOD
Correspondent
Professional Dental Technologies Therapeutics, Inc.
500 White Dr.
Batesville,  AR  72501
Correspondent Contact JOANN UNDERWOOD
Regulation Number872.6030
Classification Product Code
EJR  
Date Received10/29/2003
Decision Date 01/07/2004
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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