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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
Applicant
Envisiontec GmbH
Brusseler Strabe 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
Classification Product Code
MQC  
Subsequent Product Code
EBI  
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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