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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resin, Denture, Relining, Repairing, Rebasing
510(k) Number K102347
Device Name GRANDTEC
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 Number872.3760
Classification Product Code
EBI  
Date Received08/19/2010
Decision Date 10/29/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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