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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Crown And Bridge, Temporary, Resin
510(k) Number K091894
Device Name TEMPORARY C&B COMPOSITE
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 Number872.3770
Classification Product Code
EBG  
Date Received06/24/2009
Decision Date 07/23/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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