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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Crown And Bridge, Temporary, Resin
510(k) Number K193553
Device Name VarseoSmile Temp
Applicant
Bego Bremer Goldschlagerei Wilh. Herbst GmbH & Co. KG
Wilhelm-Herbst-Str. 1
Bremen,  DE 28359
Applicant Contact Tanja Gotz
Correspondent
Bego Bremer Goldschlagerei Wilh. Herbst GmbH & Co. KG
Wilhelm-Herbst-Str. 1
Bremen,  DE 28359
Correspondent Contact Tanja Gotz
Regulation Number872.3770
Classification Product Code
EBG  
Date Received12/20/2019
Decision Date 05/18/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
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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