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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name abutment, implant, dental, endosseous
510(K) Number K122559
Model SEVERAL
Device Name BIODENTA DENTAL IMPLANT SYSTEM - ABUTMENTS
Applicant
BIODENTA SWISS AG
tramstrasse 16
berneck, 
Contact david eiler
Regulation Number872.3630
Classification Product Code
NHA  
Date Received08/22/2012
Decision Date 05/03/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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