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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 K151956
Device Name Admira Fusion x-tra
Applicant
Voco GmbH
Anton-Flettner-Str. 1-3
Cuxhaven,  DE 27472
Applicant Contact M TH PLAUMANN
Correspondent
Voco GmbH
Anton-Flettner-Str. 1-3
Cuxhaven,  DE 27472
Correspondent Contact T GERKENSMEIER
Regulation Number872.3690
Classification Product Code
EBF  
Date Received07/15/2015
Decision Date 10/20/2015
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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