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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, Long-Term Temporary, Resin
510(k) Number K231591
Device Name V-Print c&b temp
Applicant
Voco GmbH
Anton-Flettner-Str. 1-3
Cuxhaven,  DE 27472
Applicant Contact Sarah Schaudel
Correspondent
Voco GmbH
Anton-Flettner-Str. 1-3
Cuxhaven,  DE 27472
Correspondent Contact Sarah Schaudel
Regulation Number872.3770
Classification Product Code
POW  
Subsequent Product Code
EBG  
Date Received06/01/2023
Decision Date 07/31/2023
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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