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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
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 Number872.3690
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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