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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name material, tooth shade, resin
510(k) Number K112374
Device Name X-TRA BASE
Original Applicant
VOCO GMBH
anton-flettner-strasse 1-3
cuxhaven,  DE d-27472
Original Contact t. gerkensmeier
Regulation Number872.3690
Classification Product Code
EBF  
Date Received08/17/2011
Decision Date 10/20/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
statement statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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