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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 K201795
Device Name Transcend
Applicant
Ultradent Product, Inc.
505 W. Ultradent Dr. (10200 South)
South Jordan,  UT  84095
Applicant Contact Karen Kakunes
Correspondent
Ultradent Product, Inc.
505 W. Ultradent Dr. (10200 South)
South Jordan,  UT  84095
Correspondent Contact Karen Kakunes
Regulation Number872.3690
Classification Product Code
EBF  
Date Received06/30/2020
Decision Date 09/28/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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