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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 K201668
Device Name VarseoSmile Crown plus
Applicant
BEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG
Wilhelm-Herbst-Straße 1
bremen,  DE 28359
Applicant Contact tanja goetz
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
saint paul,  MN  55114
Correspondent Contact prithul bom
Regulation Number872.3690
Classification Product Code
EBF  
Date Received06/19/2020
Decision Date 06/23/2020
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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