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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Tooth Bonding, Resin
510(k) Number K141610
Device Name FUTURABOND M+
Applicant
Voco GmbH
Anton-Flettner-Strasse 1-3
Cuxhaven,  DE 27472
Applicant Contact T. GERKENSMEIER
Correspondent
Voco GmbH
Anton-Flettner-Strasse 1-3
Cuxhaven,  DE 27472
Correspondent Contact T. GERKENSMEIER
Regulation Number872.3200
Classification Product Code
KLE  
Date Received06/16/2014
Decision Date 08/01/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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