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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powder, Porcelain
510(k) Number K201608
Device Name GenesisZr UHT700 Zirconia
Applicant
United Dental Resources Corporation
70 Towncenter Dr.
University Park,  IL  60417
Applicant Contact John Von Thaden
Correspondent
United Dental Resources Corporation
70 Towncenter Dr.
University Park,  IL  60417
Correspondent Contact John Von Thaden
Regulation Number872.6660
Classification Product Code
EIH  
Date Received06/15/2020
Decision Date 01/28/2021
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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