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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 K203641
Device Name E-Denture Pro
Applicant
Envisiontec GmbH
Brusseler Straße 51
Gladbeck,  DE D-45968
Applicant Contact Ruediger van Bernum
Correspondent
Qserve Group, Us, Inc.
7949 Beaumont Green E. Dr.
Indianapolis,  IN  46250
Correspondent Contact Patsy J. Trisler
Regulation Number872.3760
Classification Product Code
EBI  
Date Received12/14/2020
Decision Date 03/30/2021
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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