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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 K053392
Device Name FUTURABOND NR SINGLE DOSE
Applicant
Voco GmbH
Anton-Flettner-Strasse 1-3
Cuxhaven,  DE D-27472
Applicant Contact MICHAEL SUS
Correspondent
Voco GmbH
Anton-Flettner-Strasse 1-3
Cuxhaven,  DE D-27472
Correspondent Contact MICHAEL SUS
Regulation Number872.3200
Classification Product Code
KLE  
Date Received12/05/2005
Decision Date 12/15/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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