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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement, Dental
510(k) Number K132255
Device Name ULTRACEM
Applicant
Ultradent Products Inc. / Oratech, LLC
10200 S. 505 W.
South Jordan,  UT  84095
Applicant Contact DIANE E ROGER
Correspondent
Ultradent Products Inc. / Oratech, LLC
10200 S. 505 W.
South Jordan,  UT  84095
Correspondent Contact DIANE E ROGER
Regulation Number872.3275
Classification Product Code
EMA  
Subsequent Product Code
DYH  
Date Received07/19/2013
Decision Date 10/24/2013
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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