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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resin, Denture, Relining, Repairing, Rebasing
510(k) Number K200461
Device Name Freeprint denture
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 Number872.3760
Classification Product Code
EBI  
Date Received02/25/2020
Decision Date 11/16/2020
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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