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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 K211237
Device Name UltraTemp Rez II
Applicant
Ultradent Products, Inc.
505 W. Ultradent Dr. (10200 South)
South Jordan,  UT  84095
Applicant Contact Shawn L. Quigley
Correspondent
Ultradent Products, Inc.
505 W. Ultradent Dr. (10200 South)
South Jordan,  UT  84095
Correspondent Contact Adam Black
Regulation Number872.3275
Classification Product Code
EMA  
Date Received04/26/2021
Decision Date 07/13/2021
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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