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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 K151094
Device Name Mosaic Universal Composite
Applicant
Ultradent Products, Inc.
505 W. 10200 S.
South Jordan,  UT  84095
Applicant Contact KAREN KAKUNES
Correspondent
Ultradent Products, Inc.
505 W. 10200 S.
South Jordan,  UT  84095
Correspondent Contact KAREN KAKUNES
Regulation Number872.3690
Classification Product Code
EBF  
Date Received04/23/2015
Decision Date 07/21/2015
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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