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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Varnish, Cavity
510(k) Number K052263
Device Name MULTIPLE (TOOTH DESENSITIZER)
Applicant
Cosmedent, Inc.
401 N. Michigan Ave. Suite 2500
Chicago,  IL  60611
Applicant Contact JAMES L SANDRIK
Correspondent
Cosmedent, Inc.
401 N. Michigan Ave. Suite 2500
Chicago,  IL  60611
Correspondent Contact JAMES L SANDRIK
Regulation Number872.3260
Classification Product Code
LBH  
Date Received08/19/2005
Decision Date 12/16/2005
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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