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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powder, Porcelain
510(k) Number K132102
Device Name BECE CAD ZIRKON HT+
Applicant
Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO
Wilhelm-Herbst-Strasse 1
Bremen,  DE 28359
Applicant Contact HEIKE GUSTKE
Correspondent
Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO
Wilhelm-Herbst-Strasse 1
Bremen,  DE 28359
Correspondent Contact HEIKE GUSTKE
Regulation Number872.6660
Classification Product Code
EIH  
Date Received07/08/2013
Decision Date 11/12/2013
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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