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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement, Dental
510(k) Number K143212
Device Name Bifix Temp
Applicant
Voco GmbH
Anto-Flettner-Str. 1-3
Cuxhaven,  DE 27472
Applicant Contact M. Th. Plaumann
Correspondent
Voco GmbH
Anto-Flettner-Str. 1-3
Cuxhaven,  DE 27472
Correspondent Contact T. Gerkensmeier
Regulation Number872.3275
Classification Product Code
EMA  
Date Received11/10/2014
Decision Date 05/01/2015
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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