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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 K102354
Device Name GRANDIO SO HEAVY FLOW
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 Received08/19/2010
Decision Date 11/08/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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