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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Varnish, Cavity
510(k) Number K261404
Device Name UltraEZ
Applicant
Ultradent Products, Inc.
505 W. Ultradent Dr. (10200 South)
South Jordan,  UT  84095
Applicant Contact Wendy Collard
Correspondent
Third Party Review Group, LLC
7 Giralda Farms, Suite 120a
Madison,  NJ  07940
Correspondent Contact Dave Yungvirt
Regulation Number872.3260
Classification Product Code
LBH  
Date Received04/29/2026
Decision Date 04/30/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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