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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 K220894
Device Name SmileGuard
EnvisionTEC GmbH
Brusseler Straße 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 Received03/28/2022
Decision Date 06/10/2022
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No