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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
Recalls CDRH Recalls
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