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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Crown And Bridge, Temporary, Resin
510(k) Number K200273
Device Name FREEPRINT temp
Applicant
Detax GmbH & Co. KG
Carl-Zeiss-Strasse 4
Ettlingen,  DE 76275
Applicant Contact Markus Stratmann
Correspondent
Qserve Consultancy B.V.
Utrechtseweg 310 - Bldg. B42
Arnhem,  NL 6812 AR
Correspondent Contact Jan-Paul Van Loon
Regulation Number872.3770
Classification Product Code
EBG  
Date Received02/04/2020
Decision Date 10/27/2020
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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