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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 K210940
Device Name LuxaPrint Ortho Plus
Applicant
Dmg Digital Enterprises SE
Elbgaustrasse 248
Hamburg,  DE 22547
Applicant Contact Stephan Schafer
Correspondent
Delphi Medical Device Consulting, Inc.
5 Whitcomb Ave.
Ayer,  MA  01432
Correspondent Contact Pamela Papineau
Classification Product Code
MQC  
Subsequent Product Code
EBI  
Date Received03/29/2021
Decision Date 09/03/2021
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
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