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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 K201937
Device Name Ceramir Restore QuikCap
Applicant
Doxa Dental AB
Axel Johanssons Gata 4-6
Uppsala,  SE 75450
Applicant Contact Anna-Lisa Tiensuu
Correspondent
Doxa Dental AB
Axel Johanssons Gata 4-6
Uppsala,  SE 75450
Correspondent Contact Anna-Lisa Tiensuu
Regulation Number872.3275
Classification Product Code
EMA  
Date Received07/13/2020
Decision Date 11/13/2020
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
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