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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 K120822
Model 048.703, 048.704, 048.705, 022.2651, 022.4651
Device Name STRAUMANN CARES VARIOBASE ABUTMENT NNC, STRAUMANN CARES VARIOBASE ABUTMENT RN, STRAUMANN CARES VARIOBASE ABUTMENT WN, ST
Original Applicant
INSTITUT STRAUMANN AG
peter-merian-weg 12
basel,  SZ ch-4052
Original Contact andreas petermann
Regulation Number872.3630
Classification Product Code
NHA  
Date Received03/19/2012
Decision Date 12/21/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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