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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K152004
Device Name Nanova Universal Composite
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 Number872.3690
Classification Product Code
EBF  
Date Received07/20/2015
Decision Date 11/17/2015
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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