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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K210977
Device Name E-Dent 1000
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
Regulation Number872.3690
Classification Product Code
EBF  
Subsequent Product Codes
EBI   ELM  
Date Received04/01/2021
Decision Date 05/25/2021
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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