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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 K130486
Device Name FUTURABOND UNIVERSAL
Applicant
Voco GmbH
Anton-Flettner-Strasse 1-3
Cuxhaven,  DE D-27472
Applicant Contact T. GERKENSMEIER
Correspondent
Voco GmbH
Anton-Flettner-Strasse 1-3
Cuxhaven,  DE D-27472
Correspondent Contact T. GERKENSMEIER
Regulation Number872.3200
Classification Product Code
KLE  
Subsequent Product Code
EMA  
Date Received02/25/2013
Decision Date 06/20/2013
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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