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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 K262228
Device Name Transcend Bulk Fill Flowable Composite
Applicant
Ultradent Products, Inc.
505 W. Ultradent Dr.
South Jordan,  UT  84095
Applicant Contact Ruth Gardner
Correspondent
Third Party Review Group, LLC
1887 Whitney Mesa Dr.
Suite 1960
Henderson,  NV  89014
Correspondent Contact Dave Yungvirt
Regulation Number872.3690
Classification Product Code
EBF  
Subsequent Product Code
DYH  
Date Received06/30/2026
Decision Date 07/01/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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