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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name mouthguard, prescription
510(k) Number K201173
Device Name E-Guard
EnvisionTEC GmbH
Brusseler Strabe 51
Gladbeck,  DE D-45968
Applicant Contact Ruediger van Bernum
Qserve Group US, Inc.
7949 Beaumont Green East Drive
Indianapolis,  IN  46250
Correspondent Contact Patsy J. Trisler
Classification Product Code
Subsequent Product Code
Date Received05/01/2020
Decision Date 11/27/2020
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls