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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 K201091
Device Name V-Print splint
Applicant
Voco GmbH
Anton-Flettner-Str. 1-3
Cuxhaven,  DE 27472
Applicant Contact M. Th. Plaumann
Correspondent
Voco GmbH
Anton-Flettner-Str. 1-3
Cuxhaven,  DE 27472
Correspondent Contact T. Gerkensmeier
Classification Product Code
MQC  
Date Received04/23/2020
Decision Date 11/06/2020
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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