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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cleanser, Root Canal
510(k) Number K061689
Device Name AQUATINE EC ENDODONTIC CLEANSER
Applicant
Puricore, Inc.
320 King Of Prussia Rd.
Suite 200
Radnor,  PA  19087
Applicant Contact HOWARD MANN
Correspondent
Puricore, Inc.
320 King Of Prussia Rd.
Suite 200
Radnor,  PA  19087
Correspondent Contact HOWARD MANN
Classification Product Code
KJJ  
Date Received06/15/2006
Decision Date 08/24/2006
Decision Substantially Equivalent (SESE)
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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