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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alloy, Metal, Base
510(k) Number K123929
Device Name BEGOPAL+
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 Number872.3710
Classification Product Code
EJH  
Date Received12/20/2012
Decision Date 03/14/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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