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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 K140349
Device Name STARBRIGHT 5% SODIUM FLUORIDE VARNISH
Applicant
Nanova Biomaterials, Inc.
3806 Mojave Ct.
Columbia,  MO  65202
Applicant Contact ANDREW RITTS
Correspondent
Nanova Biomaterials, Inc.
3806 Mojave Ct.
Columbia,  MO  65202
Correspondent Contact ANDREW RITTS
Regulation Number872.3260
Classification Product Code
LBH  
Date Received02/19/2014
Decision Date 09/22/2014
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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